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Pericapsular Nerve Group Block (PENG) for Hip Surgery

NCT05118620 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-06-03

No results posted yet for this study

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

Interventions

DRUG

Active bupivacaine 0.375% PENG block

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

DRUG

Placebo normal saline PENG block

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

Sponsors & Collaborators

Principal Investigators

  • Brian M Ilfeld, MD, MS · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118620 on ClinicalTrials.gov