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PENG Block vs. Local Anesthetic for Hip Replacement Anesthesia

N/A

Recruiting

Led By Shalini Dhir, FRCPC

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing THA with a direct lateral surgical approach (transgluteal approach)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-24 hours following completion of spinal anesthesia

Summary

This trial will study a new technique called the pericapsular nerve group (PENG) block for patients undergoing hip replacement surgery. The current standard treatment involves injecting a mix of local anesthetic,

Who is the study for?

This trial is for adults over 18 years old who are having a total hip arthroplasty (hip replacement surgery) using a specific surgical approach. Participants must be able to give consent. It's not suitable for those with conditions that rule out the use of local anesthetics or nerve blocks.

What is being tested?

The study compares two pain management methods in hip surgery: PENG block, which numbs certain nerves, and the standard care involving local anesthetic infiltration possibly mixed with morphine and NSAIDs. The goal is to see if PENG can match or exceed current methods in pain relief and cost-effectiveness.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, numbness beyond the targeted area, allergic reactions to medications used, and less commonly nerve damage or infection from the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a hip replacement through a side (lateral) approach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-24 hours following completion of spinal anesthesia

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-24 hours following completion of spinal anesthesia

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-24 hours following completion of spinal anesthesia for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

PENG block impact on post-operative pain scores

Secondary study objectives

PENG block impact on quadriceps muscle strength post-operatively

Patient opioid consumption 24 hours period after spinal anesthesia procedure.

Time spent in post-anesthesia care unit (PACU) following surgery

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PENG BlockExperimental Treatment1 Intervention

Participants will receive ultrasound-guided PENG block (PENG group) with local anesthetics (20 ml of 0.5% ropivacaine) before administration of spinal anesthesia.

Group II: Control GroupPlacebo Group1 Intervention

Participants will receive a sham PENG block performed with 20ml of normal saline solution before spinal anesthesia. After, patients will receive ILAI (performed by the operating surgeon) with a plain solution of ropivacaine 0.25% 60ml.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PENG Block

2022

Completed Phase 3

~400

0 / 1Eligibility criteria met