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Pericapsular Nerve Group Block (PENG) for Hip Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05118620
Recruitment Status : Not yet recruiting
First Posted : November 12, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:

This will be a randomized comparison of pericapsular nerve group (PENG) blocks with bupivacaine and a placebo control (PENG blocks with normal saline). The overall objective of the proposed research is to determine the relative risks and benefits of a single-injection PENG block to provide postoperative analgesia following hip arthroscopy.

Hypothesis 1: Following hip arthroscopy, participants with a PENG block will experience less pain in the recovery room compared with current standard-of-care as measured with the Numeric Rating Scale (NRS).

Hypothesis 2: Following hip arthroscopy, participants with a PENG block will consume less opioid in the operating and recovery rooms compared with current standard-of-care as measured in oral morphine milligram equivalents.

Primary end point: In order to claim that PENG blocks are superior to placebo overall, at least one of these two hypotheses must demonstrate PENG superiority while the other cannot demonstrate inferiority.


Condition or disease Intervention/treatment Phase
Hip Arthropathy Postoperative Pain, Acute Pain, Postoperative Drug: Active bupivacaine 0.375% PENG block Drug: Placebo normal saline PENG block Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Triple (Participant, Care Provider, Investigators/Outcomes Assessors) Study solution containing either local anesthetic (bupivacaine) or normal saline will be prepared by the University of California San Diego Investigational Drug Study Service. Both bupivacaine and normal saline are clear and indistinguishable visually.
Primary Purpose: Treatment
Official Title: Pericapsular Nerve Group Block (PENG): A Randomized, Triple-Masked, Placebo-Controlled Clinical Trial
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Active Treatment
This group will receive a single injection PENG nerve block of bupivacaine 0.375% (20 mL)
Drug: Active bupivacaine 0.375% PENG block
A PENG block with bupivacaine 0.375% and epinephrine will be administered using ultrasound-guidance
Other Name: Active Pericapsular Nerve Group block

Placebo Comparator: Placebo
This group will receive a single injection PENG nerve block with normal saline (20 mL)
Drug: Placebo normal saline PENG block
A PENG block with normal saline and epinephrine will be administered using ultrasound-guidance
Other Name: Placebo Pericapsular Nerve Group block




Primary Outcome Measures :
  1. Pain scores within the recovery room as measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: From admission to the recovery room following surgery until discharge from the recovery room, assessed up to 72 hours. In order to claim PENG blocks are superior to placebo overall at least 1 of the 2 primary hypotheses must demonstrate PENG superiority ]
    Pain measured using the numeric rating scale, collected within the recovery room for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  2. Total opioid consumption within the recovery room (measured in intravenous morphine equivalents) [ Time Frame: From admission to the recovery room following surgery until discharge from the recovery room, assessed up to 72 hours. In order to claim PENG blocks are superior to placebo overall at least 1 of the 2 primary hypotheses must demonstrate PENG superiority ]
    Total opioid consumption within the recovery room (measured in intravenous morphine equivalents)


Secondary Outcome Measures :
  1. "Average" pain with movement during postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: From discharge from the recovery room until the data collection phone call on postoperative day 1 ]
    "Average" pain with movement during postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since discharge from the recovery room. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  2. "Worst" pain with movement on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: From discharge from the recovery room until the data collection phone call on postoperative day 1 ]
    "Worst" pain during postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since discharge from the recovery room. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  3. "Average" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: From discharge from the recovery room until the data collection phone call on postoperative day 1 ]
    "Average" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since discharge from the recovery room. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  4. "Worst" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: From discharge from the recovery room until the data collection phone call on postoperative day 1 ]
    "Worst" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since discharge from the recovery room. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  5. Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 1(measured in intravenous morphine equivalents) [ Time Frame: From recovery room discharge until the data collection phone call on postoperative day 1 ]
    Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 1(measured in intravenous morphine equivalents)

  6. Difficulty sleeping due to pain the evening of surgery [ Time Frame: Difficulty sleeping due to pain the evening of surgery, assessed the day following surgery ]
    Difficulty sleeping due to pain the evening of surgery as either "yes" or "no", assessed the day following surgery

  7. Awakenings to pain the evening of surgery [ Time Frame: The number of awakenings due to pain the evening of surgery, assessed the day following surgery ]
    The number of awakenings due to pain the evening of surgery, assessed the day following surgery

  8. Change in quadriceps strength between pre- and post-block measurements, as measured with an isometric force electromechanical dynamometer [ Time Frame: Immediately before and 20-30 minutes after application of the nerve block ]
    Change in maximum voluntary isometric contraction of the quadriceps muscle between pre- and post-block measurements, as measured with an isometric force electromechanical dynamometer. For quadriceps femoris evaluation, the dynamometer will be placed on the ipsilateral anterior tibia perpendicular to the tibial crest just proximal to the medial malleolus. For all measurements, participants will be asked to take 2 seconds to come to maximum effort contracting the target muscle(s), maintain this effort for 5 sec, and then relax. The measurements immediately prior to perineural ropivacaine administration will be designated baseline measurements, and all subsequent measurements will be expressed as a percentage of the pre-infusion baseline.

  9. Change in hip adductor strength between pre- and post-block measurements, as measured with an isometric force electromechanical dynamometer [ Time Frame: Immediately before and 20-30 minutes after application of the nerve block ]
    Change in maximum voluntary isometric contraction of the hip adductors between pre- and post-block measurements, as measured with an isometric force electromechanical dynamometer. For hip adductor evaluation, the femoral shaft will be held at 30º off midline and the dynamometer placed over the medial femoral epicondyle (adductor tubercle). For all measurements, participants will be asked to take 2 seconds to come to maximum effort contracting the target muscle(s), maintain this effort for 5 sec, and then relax. The measurements immediately prior to perineural ropivacaine administration will be designated baseline measurements, and all subsequent measurements will be expressed as a percentage of the pre-infusion baseline.


Other Outcome Measures:
  1. Time to perform peripheral nerve block, as measured from the time the needle first touches the patient until it is withdrawn for the final time. [ Time Frame: Preoperatively ]
    Time to perform peripheral nerve block, as measured from the time the needle first touches the patient until it is withdrawn for the final time.

  2. Study fluid injection time as measured in military format [ Time Frame: Preoperatively ]
    The time at which the study fluid is injected for the PENG block

  3. "Lowest" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: From discharge from the recovery room until the data collection phone call on postoperative day 1 ]
    "Lowest" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since discharge from the recovery room. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  4. "Current" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: At the time of the data collection phone call on postoperative day 1 ]
    "Current" pain at rest on postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  5. Number of falls from the time of recovery room discharge until the data collection phone call on postoperative day 1 [ Time Frame: From recovery room discharge until the data collection phone call on postoperative day 1 ]
    The number of falls from the time of recovery room discharge until the data collection phone call on postoperative day 1

  6. Cumulative opioid consumption postoperative day 1 (measured in oral oxycodone equivalents) [ Time Frame: From recovery room discharge until the data collection phone call on postoperative day 1 ]
    Cumulative opioid consumption postoperative day 1 (measured in oral oxycodone equivalents)

  7. Subjective weakness in the hip joint [ Time Frame: At the time of the data collection phone call on postoperative day 1 ]
    If the participant feels that they have weakness of the muscles that innervate the hip (binary answer of "yes" or "no")

  8. Time of first opioid use following recovery room discharge recorded in military time format [ Time Frame: From recovery room discharge until the data collection phone call on postoperative day 1 ]
    Time of first opioid use following recovery room discharge recorded in military time format

  9. Time of block resolution (subjective) recorded in military time format [ Time Frame: From recovery room discharge until the data collection phone call on postoperative day 1 ]
    Time of first opioid useTime of block resolution (subjective) recorded in military time format following recovery room discharge recorded in military time format

  10. Total opioid consumption within the operating room (measured in intravenous morphine equivalents) [ Time Frame: From arrival in the operating room until operating room discharge to the recovery room, assessed for up to 72 hours ]
    The total number of milligrams of opioid consumption within the operating room (measured in intravenous morphine equivalents)

  11. Anti-emetic consumption within the recovery room [ Time Frame: From admission to the recovery room until discharge from the recovery room, assessed for up to 72 hours ]
    Anti-emetic consumption within the recovery room as a binary variable ("yes" or "no")

  12. Surgical start as recorded using military time format [ Time Frame: During surgery ]
    The time of the surgical incision as recorded using military time format

  13. Surgical stop as recorded using military time format [ Time Frame: During surgery ]
    The time of the final suture insertion as recorded using military time format



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing unilateral primary hip arthroscopy with at least moderate postoperative pain anticipated
  • analgesic plan includes a general anesthetic
  • age 18 years or older

Exclusion Criteria:

  • morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
  • any planned regional analgesic or anesthetic
  • chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  • history of opioid abuse
  • any comorbidity which results in moderate or severe functional limitation
  • inability to communicate with the investigators or hospital staff
  • pregnancy
  • incarceration
  • any reason for increased risk of a peripheral nerve block (e.g. anticoagulation)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05118620


Contacts
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Contact: Brian M Ilfeld, MD, MS (858) 822-0776 bilfeld@health.ucsd.edu
Contact: Baharin Abdullah, MD (858) 220-5714 baabdullah@health.ucsd.edu

Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University of California, San Diego
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05118620    
Other Study ID Numbers: PENG Block for Hip Surgery
First Posted: November 12, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents