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CompletedNCT04919317Updated Oct 11, 2023Results posted

Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

A Phase 2 interventional study of Dexamethasone 4mg and Saline in Pain, Postoperative and Mammaplasty, sponsored by Temple University. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by Temple University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Sep 2017, registered May 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.

Read the detailed description

The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.

Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.

The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.

02

Conditions studied

  • Pain, Postoperative
  • Mammaplasty

Browse trials for

03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 56 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female
  • Age 18-80
  • Bilateral reduction mammaplasty
  • American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
  • Must choose to receive preoperative nerve block as part of pain management strategy

Exclusion criteria

Exclusion Criteria:

  • Allergy to dexamethasone or bupivacaine
  • History of postoperative nausea and vomiting following anesthesia
  • History of chronic pain conditions
  • History of narcotic abuse or dependency
  • History of chronic renal disease
  • History of chronic liver disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Placebo comparator
    Control

    Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.

    Drug: Saline

  • Experimental
    Experimental

    Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.

    Drug: Dexamethasone 4mg

Interventions

  • DrugDexamethasone 4mg

    The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

  • DrugSaline

    The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

06

What researchers measure

Primary outcomes

  1. Initial Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

  2. 4-hour Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

  3. 8-hour Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

  4. 12-hour Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

  5. 16-hour Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

  6. 20-hour Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

  7. 24-hour Visual Analog Scale (VAS) Pain Scores

    Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

    Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

  8. Narcotic Consumption

    Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization

    Time frame: Up to 24 hours postoperatively

Secondary outcomes

  1. Initial Blood Pressure

    Systolic blood pressure

    Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

  2. 4-hour Blood Pressure

    Systolic blood pressure

    Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

  3. 8-hour Blood Pressure

    Systolic blood pressure

    Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

  4. 12-hour Blood Pressure

    Systolic blood pressure

    Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

  5. 16-hour Blood Pressure

    Systolic blood pressure

    Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

  6. 20-hour Blood Pressure

    Systolic blood pressure

    Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

  7. 24-hour Blood Pressure

    Systolic blood pressure

    Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

  8. Initial Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

  9. 4-hour Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

  10. 8-hour Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

  11. 12-hour Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

  12. 16-hour Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

  13. 20-hour Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

  14. 24-hour Oxygen Saturation

    SpO2 as measured by pulse oximetry

    Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

  15. Number of Patients Administered Anti-emetics at 4-hour Intervals

    Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals

    Time frame: Initial, 4, 8, 12, 16, 20, and 24 hours

  16. Short-form 36-item (Sf-36) Quality of Life Questionnaire

    Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.

    Time frame: 1 week to 2 months postoperatively

  17. Rate of Wound Complications

    Assessment of wound complications during any postoperative clinic visit

    Time frame: 1 week to 2 months postoperatively

07

Results

Posted Jul 13, 2022
Limitations and caveats
Single-center study, which may limit the generalizability of the results The patient population is predominantly composed of racial minority communities, which may also limit the generalizability to many institutions Low SF-36 completion limited an adequate determination of the effects of the block on quality of life metrics. Some SF-36 questionnaires were completed by phone interview The COVID-19 pandemic halted enrollment for four months, which may have imposed a selection bias

Participant flow

Hospitalization and Wound Follow-up
Participant flow — Hospitalization and Wound Follow-up
MilestoneControlExperimental
Started2630
Completed2625
Not completed05
Withdrew: Protocol violation05
SF-36 Quality of Life Survey Completion
Participant flow — SF-36 Quality of Life Survey Completion
MilestoneControlExperimental
Started2625
Completed1419
Not completed126
Withdrew: Lost to follow-up126

Outcome measures

PrimaryInitial Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
Initial Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
Initial Visual Analog Scale (VAS) Pain Scores8.3 ± 1.57.4 ± 2.1
Primary4-hour Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
4-hour Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
4-hour Visual Analog Scale (VAS) Pain Scores5.5 ± 3.54.6 ± 3.6
Primary8-hour Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
8-hour Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
8-hour Visual Analog Scale (VAS) Pain Scores4.4 ± 3.93.5 ± 3.6
Primary12-hour Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
12-hour Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
12-hour Visual Analog Scale (VAS) Pain Scores3.9 ± 3.73.4 ± 3.6
Primary16-hour Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
16-hour Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
16-hour Visual Analog Scale (VAS) Pain Scores5.6 ± 2.85.4 ± 2.8
Primary20-hour Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
20-hour Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
20-hour Visual Analog Scale (VAS) Pain Scores5.8 ± 3.44.9 ± 3.8
Primary24-hour Visual Analog Scale (VAS) Pain Scores

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Time frame:
Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · score on a scale
24-hour Visual Analog Scale (VAS) Pain Scores
score on a scaleControlExperimental
24-hour Visual Analog Scale (VAS) Pain Scores5.2 ± 3.88 ± 1.4
PrimaryNarcotic Consumption

Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization

Time frame:
Up to 24 hours postoperatively
Reported as:
Mean · Oral Morphine Equivalents (OME)
Narcotic Consumption
Oral Morphine Equivalents (OME)ControlExperimental
Narcotic Consumption36.60 ± 23.9923.19 ± 17.26
SecondaryInitial Blood Pressure

Systolic blood pressure

Time frame:
Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
Initial Blood Pressure
mmHgControlExperimental
Initial Blood Pressure124.2 ± 14.8123.8 ± 13.5
Secondary4-hour Blood Pressure

Systolic blood pressure

Time frame:
Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
4-hour Blood Pressure
mmHgControlExperimental
4-hour Blood Pressure118.0 ± 10.8119.6 ± 16.4
Secondary8-hour Blood Pressure

Systolic blood pressure

Time frame:
Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
8-hour Blood Pressure
mmHgControlExperimental
8-hour Blood Pressure113.8 ± 12.2117.9 ± 17.4
Secondary12-hour Blood Pressure

Systolic blood pressure

Time frame:
Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
12-hour Blood Pressure
mmHgControlExperimental
12-hour Blood Pressure106.7 ± 8.6112.0 ± 17.8
Secondary16-hour Blood Pressure

Systolic blood pressure

Time frame:
Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
16-hour Blood Pressure
mmHgControlExperimental
16-hour Blood Pressure112.3 ± 13.6104.2 ± 8.0
Secondary20-hour Blood Pressure

Systolic blood pressure

Time frame:
Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
20-hour Blood Pressure
mmHgControlExperimental
20-hour Blood Pressure106.5 ± 12.5114.7 ± 9.6
Secondary24-hour Blood Pressure

Systolic blood pressure

Time frame:
Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · mmHg
24-hour Blood Pressure
mmHgControlExperimental
24-hour Blood Pressure108.7 ± 8.5118.3 ± 24.5
SecondaryInitial Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
Initial Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
Initial Oxygen Saturation99.4 ± 1.198.6 ± 2.1
Secondary4-hour Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
4-hour Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
4-hour Oxygen Saturation97.8 ± 1.696.9 ± 1.7
Secondary8-hour Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
8-hour Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
8-hour Oxygen Saturation98.7 ± 1.496.5 ± 2.0
Secondary12-hour Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
12-hour Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
12-hour Oxygen Saturation97.8 ± 1.597.0 ± 2.1
Secondary16-hour Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
16-hour Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
16-hour Oxygen Saturation98.8 ± 1.296.9 ± 1.6
Secondary20-hour Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
20-hour Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
20-hour Oxygen Saturation99.0 ± 0.998.3 ± 1.9
Secondary24-hour Oxygen Saturation

SpO2 as measured by pulse oximetry

Time frame:
Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Reported as:
Mean · percentage of blood oxygen saturation
24-hour Oxygen Saturation
percentage of blood oxygen saturationControlExperimental
24-hour Oxygen Saturation99.3 ± 0.697.3 ± 3.1
SecondaryNumber of Patients Administered Anti-emetics at 4-hour Intervals

Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals

Time frame:
Initial, 4, 8, 12, 16, 20, and 24 hours
Reported as:
Count of participants · Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals
ParticipantsControlExperimental
Initial45
4-hours postoperatively72
8-hours postoperatively21
12-hours postoperatively40
16-hours postoperatively00
20-hours postoperatively00
24-hours postoperatively00
SecondaryShort-form 36-item (Sf-36) Quality of Life Questionnaire

Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.

Time frame:
1 week to 2 months postoperatively
Reported as:
Mean · score on a scale
Short-form 36-item (Sf-36) Quality of Life Questionnaire
score on a scaleControlExperimental
Physical Functioning88.93 ± 15.8390.42 ± 13.98
Limitations Due to Physical Health82.14 ± 24.8679.17 ± 32.61
Limitations Due to Emotional Health88.10 ± 28.0680.56 ± 32.04
Energy/Fatigue54.64 ± 12.6352.92 ± 16.61
Emotional Well-being65.71 ± 6.4159.00 ± 13.16
Social Functioning92.50 ± 9.7188.75 ± 16.70
Pain59.64 ± 35.8464.42 ± 25.16
Overall General Health51.43 ± 13.3656.25 ± 13.69
SecondaryRate of Wound Complications

Assessment of wound complications during any postoperative clinic visit

Time frame:
1 week to 2 months postoperatively
Reported as:
Count of participants · Participants
Rate of Wound Complications
ParticipantsControlExperimental
None1919
Minor53
Moderate22
Severe01

Adverse events

Collected over 2 months postoperatively. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/26 (0%)0/26 (0%)7/26 (26.9%)
Experimental0/25 (0%)0/25 (0%)8/25 (32%)
Most frequent other events
Most frequent other events
EventControlExperimental
Wound complicationsSurgical and medical procedures7/268/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)ControlExperimentalTotal
Mean38.73 ± 13.4442.48 ± 15.1740.57 ± 14.29
Sex: Female, Male
Sex: Female, Male(Participants)ControlExperimentalTotal
Female262551
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ControlExperimentalTotal
Hispanic or Latino10818
Not Hispanic or Latino161632
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ControlExperimentalTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American151227
White268
More than one race000
Unknown or Not Reported9716
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)ControlExperimentalTotal
Mean32.65 ± 10.1234.12 ± 13.9933.37 ± 12.07
Anemia
Anemia(Participants)ControlExperimentalTotal
Count of participants459
Anxiety
Anxiety(Participants)ControlExperimentalTotal
Count of participants459
Asthma
Asthma(Participants)ControlExperimentalTotal
Count of participants4711

16 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
09

References and documents

Publications

  • Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3. PubMed 8880841 ↗
  • Broyles JM, Tuffaha SH, Williams EH, Glickman L, George TA, Lee Dellon A. Pain after breast surgery: Etiology, diagnosis, and definitive management. Microsurgery. 2016 Oct;36(7):535-538. doi: 10.1002/micr.30055. Epub 2016 Apr 4. PubMed 27043853 ↗
  • Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18. PubMed 31741068 ↗
  • Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29. PubMed 22939099 ↗
  • Vetriselvan P, Mandal B, Bhatia N, Jain V. Effect of dexamethasone on analgesic efficacy of transverse abdominis plane block in laparoscopic gynecological procedures: A prospective randomized clinical study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):165-169. doi: 10.4103/joacp.JOACP_374_17. PubMed 31303703 ↗
  • Maher DP, Serna-Gallegos D, Mardirosian R, Thomas OJ, Zhang X, McKenna R, Yumul R, Zhang V. The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone. Pain Med. 2017 Jun 1;18(6):1152-1160. doi: 10.1093/pm/pnw149. PubMed 27473629 ↗
  • Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538. PubMed 28033159 ↗
  • Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6. PubMed 30066465 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 16, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified data will be made available to other researchers if necessary

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04919317
Lead sponsor
Temple University
Responsible party
Sponsor
First posted
Jun 9, 2021
Start date
Sep 29, 2017
Primary completion
Nov 7, 2020
Completion
Nov 25, 2020
Results posted
Jul 13, 2022
Last update
Oct 11, 2023

Study contacts

Andrew A Gassman, MD, FACS
principal investigator · Lewis Katz School of Medicine at Temple University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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