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N/A

Peri-capsular Nerve Group (PENG) for Infections

Phase 4

Waitlist Available

Led By Rawad Hamzi, MD

Research Sponsored by Wake Forest University Health Sciences

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 hour 24

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two methods for pain relief after hip replacement surgery. One method aims to reduce pain without causing muscle weakness, while the other can lead to muscle weakness. The goal is to find out which method helps patients recover faster.

Eligible Conditions

Infections
Postoperative Pain
Hip Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Numeric Rating Scale (NRS) Pain Score

Secondary study objectives

Distance Ambulated

Motor Strength

NRS Pain Score

+1 more

Side effects data

From 2023 Phase 4 trial • 154 Patients • NCT05261009

Right hip dislocation

100%

80%

60%

40%

20%

Study treatment Arm

Peri-capsular Nerve Group (PENG)

Lumbar Plexus Block (LPB)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peri-capsular Nerve Group (PENG)Experimental Treatment1 Intervention

Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.

Group II: Lumbar Plexus Block (LPB)Active Control1 Intervention

Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peri-capsular Nerve Group (PENG)

2022

Completed Phase 4

~160

Do I qualify?Apply below to find out