PENG Block Versus LP Block for THA Postop Pain

PENG Block Versus LP Block for Postoperative Analgesia After Anterior Total Hip

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Hip Pain Chronic
• Intervention / Treatment: Drug: Peri-capsular Nerve Group (PENG); Other: Lumbar Plexus Block (LPB)

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Peri-capsular Nerve Group (PENG); PENG block for postoperative pain management
Active Comparator: 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.	Other: Lumbar Plexus Block (LPB); LPB for postoperative pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain Score	a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 12 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.	hour 12
NRS Pain Score	a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 18 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.	hour 18
NRS Pain Score	a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 24 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.	hour 24
Distance Ambulated	Recorded in feet during first physical therapy	hour 24
Motor Strength	straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement	hour 6
Time in Minutes Until Opioid Administration	Time to first dose of opioid rescue for postoperative pain management - This outcome was evaluated in time to first opioid dose, which was measured in hours - no analysis for mean, median, or any of the others suggested - It was calculated as time of block to time of first opioid dose-hours and minutes.	hour 24

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rawad Hamzi, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRB00078699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No