PENG Block Versus LP Block for THA Postop Pain

NCT05261009 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00078699
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Hip Pain Chronic

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) Pain Score

  a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at six hours following block placement. Equivalency will be defined as a difference of less than one point in either direction on the eleven-point NRS pain scale. Score ranges from 0-10 with a higher score denoting more pain.

  hour 6

Secondary Outcomes (6)

• NRS Pain Score

  hour 12

• NRS Pain Score

  hour 18

• NRS Pain Score

  hour 24

• Time in Minutes Until Opioid Administration

  hour 24

• Motor Strength

  hour 6

Study Arms (2)

Peri-capsular Nerve Group (PENG)

EXPERIMENTAL

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.

Drug: Peri-capsular Nerve Group (PENG)

Lumbar Plexus Block (LPB)

ACTIVE COMPARATOR

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.

Other: Lumbar Plexus Block (LPB)

Interventions

Peri-capsular Nerve Group (PENG) DRUG

PENG block for postoperative pain management

Peri-capsular Nerve Group (PENG)

Lumbar Plexus Block (LPB) OTHER

LPB for postoperative pain management

Lumbar Plexus Block (LPB)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Daryl Henshaw, MD
• Organization: Wake Forest School of Medicine

dhenshaw@wakehealth.edu

336-716-4498

Study Officials

• Rawad Hamzi, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 2, 2022
• Study Start: June 13, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: May 21, 2024
• Results First Posted: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)