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CompletedNCT03250507Updated Dec 21, 2022Results posted

Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

A Phase 4 interventional study of Bupivacaine and Liposomal bupivacaine in Hysterectomy, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Read the detailed description

All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.

02

Conditions studied

  • Hysterectomy

Keywords

  • TAP block
  • Liposomal bupivicaine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion criteria

Exclusion Criteria:

  • Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Bupivacaine

    Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine

    Drug: Bupivacaine

  • Active comparator
    Liposomal bupivacaine

    Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine.

    Drug: Liposomal bupivacaine · Drug: Saline

  • Experimental
    Liposomal bupivacaine and bupivacaine

    Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine.

    Drug: Bupivacaine · Drug: Liposomal bupivacaine

Interventions

  • DrugBupivacaine

    0.25% bupivacaine for TAP block

    Also known as: Marcaine, Sensorcaine

  • DrugLiposomal bupivacaine

    Exparel for TAP block

    Also known as: Exparel

  • DrugSaline

    Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

05

What researchers measure

Primary outcomes

  1. Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)

    Total opioid consumption

    Time frame: 0 - 72 hours post-operatively

  2. Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given

    time to first opioid given

    Time frame: 0 - 72 hours post-operatively

Secondary outcomes

  1. Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied

    Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.

    Time frame: 0 - 72 hours post-operatively

  2. Length of Stay in the Hospital

    Length of stay in the hospital, maximum time until discharge from the hospital

    Time frame: until the patient is discharged from the hospital

  3. Number of Patients With Local Anesthetic Toxicity

    Presence of local anesthetic toxicity

    Time frame: 0 - 72 hours post-operatively

  4. Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure

    Presence of hemodynamic instability

    Time frame: 0 - 72 hours post-operatively

  5. Pain Scores Using Visual Analogue Scale ( 0-10)

    Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

    Time frame: 0-24 postoperative pain scores

06

Results

Posted Dec 21, 2022

Participant flow

Participant flow — Overall Study
MilestoneBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Started303030
Completed303030
Not completed000

Outcome measures

PrimaryTotal Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)

Total opioid consumption

Time frame:
0 - 72 hours post-operatively
Reported as:
Median · mg morphine equivalents
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
mg morphine equivalentsBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)208 (155 to 270)203 (153 to 283)202 (116 to 325)
PrimaryTime to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given

time to first opioid given

Time frame:
0 - 72 hours post-operatively
Reported as:
Median · minutes
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
minutesBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given51 (28 to 66)63 (44 to 102)51 (24 to 84)
SecondaryPatient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied

Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.

Time frame:
0 - 72 hours post-operatively
Reported as:
Number · participants
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
participantsBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied9139
SecondaryLength of Stay in the Hospital

Length of stay in the hospital, maximum time until discharge from the hospital

Time frame:
until the patient is discharged from the hospital
Reported as:
Median · hours
Length of Stay in the Hospital
hoursBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Length of Stay in the Hospital79 (61 to 122)82 (72 to 102)80 (76 to 107)
SecondaryNumber of Patients With Local Anesthetic Toxicity

Presence of local anesthetic toxicity

Time frame:
0 - 72 hours post-operatively
Reported as:
Count of participants · Participants
Number of Patients With Local Anesthetic Toxicity
ParticipantsBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Number of Patients With Local Anesthetic Toxicity000
SecondaryNumber of Patients With Hypotension < 60 mmHg Mean Arterial Pressure

Presence of hemodynamic instability

Time frame:
0 - 72 hours post-operatively
Reported as:
Count of participants · Participants
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
ParticipantsBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure015
SecondaryPain Scores Using Visual Analogue Scale ( 0-10)

Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

Time frame:
0-24 postoperative pain scores
Reported as:
Median · units on a scale
Pain Scores Using Visual Analogue Scale ( 0-10)
units on a scaleBupivacaineLiposomal BupivacaineLiposomal Bupivacaine and Bupivacaine
Pain Scores Using Visual Analogue Scale ( 0-10)8 (7 to 9)7 (6 to 7)7 (5 to 8)

Adverse events

Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bupivacaine0/30 (0%)0/30 (0%)0/30 (0%)
Liposomal Bupivacaine0/30 (0%)0/30 (0%)0/30 (0%)
Liposomal Bupivacaine and Bupivacaine0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

13 patients were excluded from study analysis due to meeting exclusion criteria. N=25 in group Bupi, N = 27 in group Liposomal bupi, and N=25 in group liposomal bupi and bupi. 20 patients were discharged within 72 hr. Data is given for those in the hospital for 24 hr periods. For the period 24-48 hr, n = 24 in group bupivacaine, n = 26 in group liposomal, n = 25 in group mixture. For the period 48-72 hr, n = 18 for group bupivacaine, n = 20 for group liposomal, and n = 19 for group mixture. \*

Age, Categorical
Age, Categorical(Participants)BupivacaineLiposomal BupivacaineLiposomal Bupivacaine and BupivacaineTotal
<=18 years0000
Between 18 and 65 years30303090
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)BupivacaineLiposomal BupivacaineLiposomal Bupivacaine and BupivacaineTotal
Female30303090
Male0000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)BupivacaineLiposomal BupivacaineLiposomal Bupivacaine and BupivacaineTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(participants)BupivacaineLiposomal BupivacaineLiposomal Bupivacaine and BupivacaineTotal
United States30303090
07

Study locations

1 site
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
08

References and documents

Publications

  • Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11. PubMed 33432496 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 22, 2016

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

Individual participant data

Plan to share: No — Individual patient data will be available to only study researchers.

09

Registry details

Key details

Study ID
NCT03250507
Lead sponsor
Henry Ford Health System
Responsible party
Mohamed Rida Alsaden (Anesthesiologist, Henry Ford Health System) — Principal investigator
First posted
Aug 15, 2017
Start date
Mar 13, 2017
Primary completion
Jan 30, 2019
Completion
Jan 30, 2019
Results posted
Dec 21, 2022
Last update
Dec 21, 2022

Study contacts

Mohamed-Rida Alsaden, MBChB FRCPC
principal investigator · Henry Ford Hospital

Oversight

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

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