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Nerve Blocks for Total Hip Replacement Recovery (PENG Trial)

N/A
Recruiting
Led By Sébastien Garneau, MD, FRCPC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients over 18 years old undergoing a total hip replacement surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 1 to 2 days
Awards & highlights

PENG Trial Summary

This trial will test whether a combination of two types of nerve blocks can improve recovery quality after hip replacement surgery.

Who is the study for?
This trial is for adults over 18 who are having total hip replacement surgery and can communicate with the medical team. It's not for those allergic to local anesthetics, with severe bleeding disorders, infections at the injection site, nerve damage in certain leg areas, regular opioid users before surgery, or anyone who can't consent.Check my eligibility
What is being tested?
The study tests if combining two types of nerve blocks—PENG (Pericapsular Nerve Group) and LFCN (Lateral Femoral Cutaneous Nerve)—with Ropivacaine improves recovery quality after hip replacement compared to using saline solution.See study design
What are the potential side effects?
Possible side effects include discomfort at the injection site, weakness or numbness in the leg due to nerve blockage which usually resolves as the anesthesia wears off. Allergic reactions to Ropivacaine may occur but are rare.

PENG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and scheduled for total hip replacement surgery.

PENG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 1 to 2 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 1 to 2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of recovery, QoR15 (Quality of Recovery 15)
Secondary outcome measures
Difficulty of realization of the block
In-hospital stay for hospitalized patients
Mild cognitive impairment assessment using the Montreal Cognitive Assessment (MoCA)
+5 more

PENG Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PENG and LFCN blocks with ropivacaineActive Control1 Intervention
For the PENG block, and after negative aspiration, 20 ml of a solution of ropivacaine 0.5% with epinephrine 2.5 mcg/ml will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same solution will be injected with the same needle.
Group II: PENG and LFCN blocks with saline solutionPlacebo Group1 Intervention
For the PENG block, and after negative aspiration, 20 ml of a saline solution will be injected in 5 ml aliquots. Then, for the LFCN block, the lateral femoral cutaneous nerve will be localized, infero-medially to the antero-superior iliac spine, superficially to the sartorius muscle and 5 ml of the same saline solution will be injected with the same needle.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,563 Total Patients Enrolled
5 Trials studying Postoperative Pain
480 Patients Enrolled for Postoperative Pain
Sébastien Garneau, MD, FRCPCPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
4 Previous Clinical Trials
245 Total Patients Enrolled
1 Trials studying Postoperative Pain
60 Patients Enrolled for Postoperative Pain

Media Library

PENG and LFCN blocks with ropivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04245280 — N/A
Postoperative Pain Research Study Groups: PENG and LFCN blocks with ropivacaine, PENG and LFCN blocks with saline solution
Postoperative Pain Clinical Trial 2023: PENG and LFCN blocks with ropivacaine Highlights & Side Effects. Trial Name: NCT04245280 — N/A
PENG and LFCN blocks with ropivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245280 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants for this experiment?

"Affirmative, clinicaltrials.gov clearly states that this research is currently seeking volunteers. This project was initially published on May 4th 2021 and had its latest update on October 11th 2022; 74 people are needed at a single facility for the trial."

Answered by AI

What bodily afflictions does the combination of PENG and LFCN blocks with ropivacaine typically help to alleviate?

"PENG and LFCN blocks with ropivacaine are a common approach to anesthesia procedures, but this technique is also applicable for the management of labor pain, postoperative discomfort, and other surgeries."

Answered by AI

Are volunteers currently being accepted for this clinical experiment?

"That is accurate. As indicated by records on clinicaltrials.gov, this medical trial which was first posted on May 4th 2021 has resumed its search for participants and is currently enrolling 74 patients from one specific site."

Answered by AI
~2 spots leftby Jun 2024