PENG Block Versus LP Block for THA Postop Pain

NCT ID: NCT05261009

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2023-07-20

Brief Summary

The purpose of this randomized, double blinded, prospective study is to compare the postoperative analgesia provided by the PENG block to that provided by the LPB for patients undergoing primary anterior approach THA.

Detailed Description

Regional anesthesia procedures represent a common modality for postoperative analgesia after total hip arthroplasty surgeries (THA). The standard practice many years has been the Lumbar Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While the LPB offers analgesia from the associated sensory block, it also blocks motor fibers, leading to lower extremity weakness that could potentially delay the patient's ability to participate in early physical therapy and may thereby delay discharge. In the past several years, newer regional anesthesia block approaches have been described and investigated in an attempt to provide patients with postoperative analgesia while avoiding associated muscle weakness, facilitating earlier physical therapy participation and discharge. One such nerve block is the peri-capsular nerve group (PENG) block, which anesthetizes the articular branches of the femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip joint capsule without consistently causing lower extremity weakness2. Some institutions are utilizing the PENG block to provide postoperative analgesia and facilitate early mobilization. There are currently no prospective studies that directly compare the efficacy of LPB to PENG block for providing postoperative analgesia after THA.

Conditions

Pain, Postoperative; Hip Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Peri-capsular Nerve Group (PENG)

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 Type: EXPERIMENTAL

Peri-capsular Nerve Group (PENG)

Intervention Type: DRUG

PENG block for postoperative pain management

Lumbar Plexus Block (LPB)

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.

Group Type: ACTIVE_COMPARATOR

Lumbar Plexus Block (LPB)

Intervention Type: OTHER

LPB for postoperative pain management

Interventions

Peri-capsular Nerve Group (PENG)

PENG block for postoperative pain management

Intervention Type: DRUG

Lumbar Plexus Block (LPB)

LPB for postoperative pain management

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• elective primary total hip arthroplasty surgery anterior approach
• provided informed consent
• no contraindications to medications used in providing the analgesic blocks

Exclusion Criteria

• contraindications to regional anesthesia, such as an allergy to amide local anesthetics
• pre-existing coagulopathy or thrombocytopenia <100,000
• refusal of analgesic block for pain management
• presence of an progressive lower extremity neurological deficit
• localized or systemic infection
• chronic use of high dose opioid analgesics (defined as daily use greater than 60 mg oxycodone equivalents)
• pregnant
• refusal of consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rawad Hamzi, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00078699

Identifier Type: -

Identifier Source: org_study_id