PENG Block Versus LP Block for THA Postop Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261009
• Other study ID #: IRB00078699
• Status: Completed
• Phase: Phase 4
• Start date: June 13, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Pain Chronic
• Pain, Postoperative

Intervention

Drug:
• Peri-capsular Nerve Group (PENG)
PENG block for postoperative pain management

Other:
• Lumbar Plexus Block (LPB)
LPB for postoperative pain management

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Time in Hours 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
Secondary	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
Secondary	Distance Ambulated	Recorded in feet during first physical therapy	hour 24