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Active Treatment for Hip Arthritis

Phase 4
Waitlist Available
Led By Brian M Ilfeld, MD, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights

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.

Eligible Conditions
  • Hip Arthritis
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Total opioid consumption within the recovery room (measured in intravenous morphine equivalents)
Secondary outcome measures
"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
"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
"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
+6 more
Other outcome measures
"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
"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
Anti-emetic consumption within the recovery room
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment1 Intervention
This group will receive a single injection PENG nerve block of bupivacaine 0.375% (20 mL)
Group II: PlaceboPlacebo Group1 Intervention
This group will receive a single injection PENG nerve block with normal saline (20 mL)

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,407 Total Patients Enrolled
Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity of California, San Diego
19 Previous Clinical Trials
1,541 Total Patients Enrolled

Frequently Asked Questions

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~0 spots leftby Apr 2025