Pericapsular Nerve Group Block (PENG) for Hip Surgery

NCT05118620 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: PENG Block for Hip Surgery
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthropathy; Postoperative Pain, Acute; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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)

  Total opioid consumption within the recovery room (measured in intravenous morphine equivalents)

  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

Secondary Outcomes (9)

• "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

  From discharge from the recovery room until the data collection phone call on postoperative day 1

• "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

  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. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  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. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale

  From discharge from the recovery room 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)

  From recovery room discharge until the data collection phone call on postoperative day 1

Other Outcomes (13)

• 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.

  Preoperatively

• Study fluid injection time as measured in military format

  Preoperatively

• "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

  From discharge from the recovery room until the data collection phone call on postoperative day 1

Study Arms (2)

Active Treatment

EXPERIMENTAL

This group will receive a single injection PENG nerve block of bupivacaine 0.375% (20 mL)

Drug: Active bupivacaine 0.375% PENG block

Placebo

PLACEBO COMPARATOR

This group will receive a single injection PENG nerve block with normal saline (20 mL)

Drug: Placebo normal saline PENG block

Interventions

Active bupivacaine 0.375% PENG block DRUG

A PENG block with bupivacaine 0.375% and epinephrine will be administered using ultrasound-guidance

Also known as: Active Pericapsular Nerve Group block

Active Treatment

Placebo normal saline PENG block DRUG

A PENG block with normal saline and epinephrine will be administered using ultrasound-guidance

Also known as: Placebo Pericapsular Nerve Group block

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 12, 2021
• Study Start: December 9, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

US (1)