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Active Treatment for Infections

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
Pivotal Trial
Drug Has Already Been Approved

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
  • Infections
  • Surgical Pain
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
"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 study objectives
"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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
1,180 Previous Clinical Trials
1,575,056 Total Patients Enrolled
16 Trials studying Infections
29,008 Patients Enrolled for Infections
Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity of California, San Diego
20 Previous Clinical Trials
1,660 Total Patients Enrolled
~0 spots leftby Nov 2025