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CompletedNCT01949480Updated Jan 22, 2019Results posted

Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control

An interventional study of Thoracotomy and Video-Assisted Thoracoscopic Surgery (VATS) in Paravertebral Peripheral Nerve Block and Acute Pain Management, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-22.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The overall purpose of this research study is to compare the effectiveness of ultrasound assisted paravertebral block placement versus traditional "blind" technique for postoperative analgesia following thoracotomy or visually assisted thoracoscopic surgery.

Read the detailed description

The purpose of this project is to determine if there is a difference between paravertebral block performed with ultrasound assistance and paravertebral block performed with traditional technique in terms of twenty - four hour hydromorphone (dilaudid) consumption and visual analogue pain scores at rest or with deep breathing at twenty - four hours. This study will determine if ultrasound technique used for placement of paravertebral catheter facilitates safety of paravertebral catheterization and improves therapeutic effect of paravertebral blockade for pain control after thoracotomy. The investigators will also examine if ultrasound assisted paravertebral blockade improves pulmonary status in post-thoracotomy patient.

02

Conditions studied

  • Paravertebral Peripheral Nerve Block
  • Acute Pain Management

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Keywords

  • Peripheral nerve block
  • Ultrasound guidance
  • Postoperative pain management post status thoracotomy
  • Postoperative pain management post status VATS
03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 45 is below the median of 90 across 732 interventional studies indexed under Acute Pain.

Browse Acute Pain studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. American Society of Anesthesiologists (ASA) I-III subjects
    1. Ages 18-75 years
    1. BMI \< 40
    1. Scheduled for elective thoracic surgery at University of Pittsburgh Medical Center (UPMC) Passavant and Shadyside Hospitals in Pittsburgh, Pennsylvania
    1. Patients willing and able to provide informed consent

Exclusion criteria

Exclusion Criteria:

    1. Age younger than 18 years or older than 75 years
  • (2) Any contraindication to the placement of unilateral thoracic paravertebral catheter, including local infection, hypocoagulable state.
  • (3) American Society of Anesthesiologists physical status IV or greater
  • (4) chronic painful conditions
  • (5) preoperative opioid use
  • (6) coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
  • (7) allergy to lidocaine, ropivacaine or bupivacaine
  • (8) personal or family history of malignant hyperthermia
  • (9) serum creatinine greater than 1.4 g/dl
  • (10) pregnancy or lactating.The pregnancy status will be determined by history and prior pregnancy testing when appropriate
  • (11) having an altered mental status (not oriented to place, person, or time) or emergency surgery
  • (12) comorbid conditions such as sepsis, unstable angina, congestive heart failure, moderate to severe valvular heart disease, severe chronic obstructive pulmonary disease (COPD)
  • (13) patient's inability to provide adequate informed consent
  • (14) patient refusal to nerve blocks and/or participation in the study
  • (15) respiratory support via ventilator post
  • (16) non English speaking
  • (17) allergy to contrast of iodine
  • (18) emergency surgery or any other non-elective procedure
  • (19) unstable vertebral and transverse process fractures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Traditional approach paravertebral nerve block

    After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.

    Procedure: Thoracotomy · Procedure: Video-Assisted Thoracoscopic Surgery (VATS)

  • Experimental
    Ultrasound assisted paravertebral nerve block

    The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.

    Procedure: Thoracotomy · Procedure: Video-Assisted Thoracoscopic Surgery (VATS)

Interventions

  • ProcedureThoracotomy
  • ProcedureVideo-Assisted Thoracoscopic Surgery (VATS)
06

What researchers measure

Primary outcomes

  1. Opioid Consumption at 24 Hours Postoperatively

    Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).

    Time frame: 24 hours after patient-controlled analgesia (PCA) was initiated

Secondary outcomes

  1. Sensory Level

    Sensory level as assessed by temperature and pin prick test assessed every 5 min for 30 min after nerve block as defined as the patient returning to their bed. Data below are in number of patients who didn't have any change during the ice and pin prik test.

    Time frame: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.

  2. Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing

    The pain level assessed using an 11-point numerical rating scale (NRS) with 0 indicating no pain and 10 indicating the worst pain possible with deep breathing and rest at 24 hours post PCA initiation.

    Time frame: 24 hours post PCA initiation

  3. Number of Local Anesthetic Boluses Requested by PCA

    The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.

    Time frame: 24 hours postoperatively

  4. Total Local Anesthetic Infusions Over 24- Hour Period

    The total local anesthetic infusions over 24- hour period.

    Time frame: 24 hours postoperatively

  5. Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)

    Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval. Value reported is an average of the preoperative and the 24-hour postoperative SpO2 measurements.

    Time frame: Pre-operatively and at 24 hour post-operative

  6. Incentive Spirometry

    Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation. The data is reported as a percentage in change from per-surgery measurements (post-surgery/pre-surgery).

    Time frame: Preoperatively and Postoperatively

  7. Respiratory Rate

    Respiratory rate (RR) per minute after surgery.

    Time frame: 24 hours postoperatively

  8. Forced Vital Capacity (FVC)

    Forced vital capacity (FVC) measured preoperatively and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).

    Time frame: Preoperatively and postoperatively

  9. Forced Expiratory Volume in 1 Sec (FEV1)

    Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval. Then the values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).

    Time frame: Preoperatively and postoperatively

  10. Peak Expiratory Flow Rate(PEF)

    Peak expiratory flow rate preoperatively (PEF) and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).

    Time frame: Preoperatively and postoperatively

  11. Total Number of Local Anesthetic Boluses in 24 Hours

    Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.

    Time frame: postoperatively, up to 24 hours

07

Results

Posted Jan 22, 2019

Participant flow

From July 1, 2013- May 29 2014, 45 patients scheduled for thoracic surgery were approached in the preoperative setting and consented for the study.

Participant flow — Overall Study
MilestoneTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Started2022
Completed1514
Not completed58
Withdrew: Physician decision58

Outcome measures

PrimaryOpioid Consumption at 24 Hours Postoperatively

Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).

Time frame:
24 hours after patient-controlled analgesia (PCA) was initiated
Reported as:
Mean · mg
Opioid Consumption at 24 Hours Postoperatively
mgTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Opioid Consumption at 24 Hours Postoperatively5.75 (3.9 to 7.59)6.38 (4.09 to 8.66)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.643
SecondarySensory Level

Sensory level as assessed by temperature and pin prick test assessed every 5 min for 30 min after nerve block as defined as the patient returning to their bed. Data below are in number of patients who didn't have any change during the ice and pin prik test.

Time frame:
6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.
Reported as:
Count of participants · Participants
Sensory Level
ParticipantsTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Sensory Level31
SecondaryPain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing

The pain level assessed using an 11-point numerical rating scale (NRS) with 0 indicating no pain and 10 indicating the worst pain possible with deep breathing and rest at 24 hours post PCA initiation.

Time frame:
24 hours post PCA initiation
Reported as:
Mean · units on a scale
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
units on a scaleTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
NRS at rest after 24 hrs1.73 (1.04 to 2.43)2.92 (1.99 to 3.86)
NRS during deep inspiration at 24 hrs4 (2.58 to 5.42)4.77 (3.56 to 5.98)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = .077
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.39
SecondaryNumber of Local Anesthetic Boluses Requested by PCA

The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.

Time frame:
24 hours postoperatively
Reported as:
Mean · Number of boluses requested
Number of Local Anesthetic Boluses Requested by PCA
Number of boluses requestedTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Number of Local Anesthetic Boluses Requested by PCA27.5 (13.5 to 57.2)48 (17 to 63)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.605
SecondaryTotal Local Anesthetic Infusions Over 24- Hour Period

The total local anesthetic infusions over 24- hour period.

Time frame:
24 hours postoperatively
Reported as:
Mean · mL
Total Local Anesthetic Infusions Over 24- Hour Period
mLTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Total Local Anesthetic Infusions Over 24- Hour Period173 (168 to 184)186 (175 to 197)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.104
SecondaryInspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)

Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval. Value reported is an average of the preoperative and the 24-hour postoperative SpO2 measurements.

Time frame:
Pre-operatively and at 24 hour post-operative
Reported as:
Mean · Percentage of SpO2
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
Percentage of SpO2Traditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)95 (94 to 96)94 (93 to 95)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.308
SecondaryIncentive Spirometry

Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation. The data is reported as a percentage in change from per-surgery measurements (post-surgery/pre-surgery).

Time frame:
Preoperatively and Postoperatively
Reported as:
Mean · percentage in change from per-surgery
Incentive Spirometry
percentage in change from per-surgeryTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Incentive Spirometry0.658 (0.544 to 0.773)0.716 (0.575 to 0.857)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.487
SecondaryRespiratory Rate

Respiratory rate (RR) per minute after surgery.

Time frame:
24 hours postoperatively
Reported as:
Mean · breaths per one minute
Respiratory Rate
breaths per one minuteTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Respiratory Rate17 (15.8 to 18.2)17.7 (15.9 to 19.5)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.493
SecondaryForced Vital Capacity (FVC)

Forced vital capacity (FVC) measured preoperatively and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).

Time frame:
Preoperatively and postoperatively
Reported as:
Mean · percentage in change from per-surgery
Forced Vital Capacity (FVC)
percentage in change from per-surgeryTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Forced Vital Capacity (FVC)0.551 (0.403 to 0.699)0.504 (0.395 to 0.613)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.574
SecondaryForced Expiratory Volume in 1 Sec (FEV1)

Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval. Then the values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).

Time frame:
Preoperatively and postoperatively
Reported as:
Mean · percentage in change from per-surgery
Forced Expiratory Volume in 1 Sec (FEV1)
percentage in change from per-surgeryTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Forced Expiratory Volume in 1 Sec (FEV1)0.561 (0.4 to 0.722)0.571 (0.466 to 0.675)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.913
SecondaryPeak Expiratory Flow Rate(PEF)

Peak expiratory flow rate preoperatively (PEF) and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).

Time frame:
Preoperatively and postoperatively
Reported as:
Mean · percentage in change from per-surgery
Peak Expiratory Flow Rate(PEF)
percentage in change from per-surgeryTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Peak Expiratory Flow Rate(PEF)0.568 (0.4 to 0.735)0.542 (0.42 to 0.664)
Statistical analysis
  • Traditional Approach Paravertebral Nerve Block vs Ultrasound Assisted Paravertebral Nerve Block · t-test, 2 sided · p = 0.783
SecondaryTotal Number of Local Anesthetic Boluses in 24 Hours

Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.

Time frame:
postoperatively, up to 24 hours
Reported as:
Mean · number of boluses
Total Number of Local Anesthetic Boluses in 24 Hours
number of bolusesTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Total Number of Local Anesthetic Boluses in 24 Hours1 (0 to 1.5)2 (1 to 4)

Adverse events

Collected over Adverse events collected for 24 hours post-operatively. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Traditional Approach Paravertebral Nerve Block0/20 (0%)0/20 (0%)2/20 (10%)
Ultrasound Assisted Paravertebral Nerve Block0/22 (0%)0/22 (0%)3/22 (13.6%)
Most frequent other events
Most frequent other events
EventTraditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve Block
Catheter leakingSurgical and medical procedures2/203/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Traditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve BlockTotal
<=18 years000
Between 18 and 65 years81119
>=65 years121123
Age, Continuous
Age, Continuous(years)Traditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve BlockTotal
Mean68 (59.5 to 71.5)64 (57 to 70)66 (57 to 71.5)
Sex: Female, Male
Sex: Female, Male(Participants)Traditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve BlockTotal
Female121426
Male8816
Region of Enrollment
Region of Enrollment(participants)Traditional Approach Paravertebral Nerve BlockUltrasound Assisted Paravertebral Nerve BlockTotal
United States202242
08

Study locations

2 sites
  • UPMC Presbyterian Shadyside
    Pittsburgh, Pennsylvania 15232, United States
  • UPMC Passavant
    Pittsburgh, Pennsylvania 15237, United States
09

References and documents

Publications

  • Richardson J, Sabanathan S, Jones J, Shah RD, Cheema S, Mearns AJ. A prospective, randomized comparison of preoperative and continuous balanced epidural or paravertebral bupivacaine on post-thoracotomy pain, pulmonary function and stress responses. Br J Anaesth. 1999 Sep;83(3):387-92. doi: 10.1093/bja/83.3.387. PubMed 10655907 ↗
  • Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541. PubMed 7577277 ↗
  • Matthews PJ, Govenden V. Comparison of continuous paravertebral and extradural infusions of bupivacaine for pain relief after thoracotomy. Br J Anaesth. 1989 Feb;62(2):204-5. doi: 10.1093/bja/62.2.204. PubMed 2923769 ↗
  • Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x. PubMed 7573876 ↗
  • Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30. PubMed 16199417 ↗
  • Ganapathy S, Murkin JM, Boyd DW, Dobkowski W, Morgan J. Continuous percutaneous paravertebral block for minimally invasive cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):594-6. doi: 10.1016/s1053-0770(99)90015-0. No abstract available. PubMed 10527232 ↗
  • Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004. PubMed 7618963 ↗
  • Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026. PubMed 10825328 ↗
  • Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol Scand. 1999 Aug;43(7):770-4. doi: 10.1034/j.1399-6576.1999.430714.x. PubMed 10456819 ↗
  • Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. doi: 10.1111/j.1365-2044.1995.tb05939.x. PubMed 8678263 ↗
  • Kirvela O, Antila H. Thoracic paravertebral block in chronic postoperative pain. Reg Anesth. 1992 Nov-Dec;17(6):348-50. PubMed 1286056 ↗
  • Karmakar MK, Chui PT, Joynt GM, Ho AM. Thoracic paravertebral block for management of pain associated with multiple fractured ribs in patients with concomitant lumbar spinal trauma. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):169-73. doi: 10.1053/rapm.2001.21086. PubMed 11251143 ↗
  • Chelly JE. Peripheral Nerve Blocks: A Color Atlas. 2009. Third Edition. Lippincott Williams and Wilkins.
  • Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023. PubMed 11812698 ↗
  • Evans PJ, Lloyd JW, Wood GJ. Accidental intrathecal injection of bupivacaine and dextran. Anaesthesia. 1981 Jul;36(7):685-7. doi: 10.1111/j.1365-2044.1981.tb08781.x. PubMed 6168207 ↗
  • Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14. PubMed 14570677 ↗
  • Marhofer P, Sitzwohl C, Greher M, Kapral S. Ultrasound guidance for infraclavicular brachial plexus anaesthesia in children. Anaesthesia. 2004 Jul;59(7):642-6. doi: 10.1111/j.1365-2044.2004.03669.x. PubMed 15200537 ↗
  • Luyet C, Eichenberger U, Greif R, Vogt A, Szucs Farkas Z, Moriggl B. Ultrasound-guided paravertebral puncture and placement of catheters in human cadavers: an imaging study. Br J Anaesth. 2009 Apr;102(4):534-9. doi: 10.1093/bja/aep015. Epub 2009 Feb 24. PubMed 19244265 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01949480
Lead sponsor
University of Pittsburgh
Responsible party
Anna Uskova (Clinical Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Sep 24, 2013
Start date
Jul 1, 2013
Primary completion
Jun 5, 2014
Completion
Jun 5, 2014
Results posted
Jan 22, 2019
Last update
Jan 22, 2019

Study contacts

Anna Uskova, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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