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PENG Block Versus LP Block for THA Postop Pain

Primary Purpose

Pain, Postoperative, Hip Pain Chronic

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Peri-capsular Nerve Group (PENG)
Lumbar Plexus Block (LPB)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peri-capsular Nerve Group (PENG)

Lumbar Plexus Block (LPB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Opioid administration
Average time to first dose of opioid rescue for postoperative pain management
Motor strength
straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement
Distance Ambulated
Recorded in feet during first physical therapy

Full Information

First Posted
February 10, 2022
Last Updated
September 20, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05261009
Brief Title
PENG Block Versus LP Block for THA Postop Pain
Official Title
PENG Block Versus LP Block for Postoperative Analgesia After Anterior Total Hip
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Hip Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peri-capsular Nerve Group (PENG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Lumbar Plexus Block (LPB)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Peri-capsular Nerve Group (PENG)
Intervention Description
PENG block for postoperative pain management
Intervention Type
Other
Intervention Name(s)
Lumbar Plexus Block (LPB)
Intervention Description
LPB for postoperative pain management
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) Pain Score
Description
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.
Time Frame
hour 6
Secondary Outcome Measure Information:
Title
NRS Pain Score
Description
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.
Time Frame
hour 12
Title
NRS Pain Score
Description
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.
Time Frame
hour 18
Title
NRS Pain Score
Description
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.
Time Frame
hour 24
Title
Opioid administration
Description
Average time to first dose of opioid rescue for postoperative pain management
Time Frame
hour 24
Title
Motor strength
Description
straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement
Time Frame
hour 6
Title
Distance Ambulated
Description
Recorded in feet during first physical therapy
Time Frame
hour 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rawad Hamzi, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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PENG Block Versus LP Block for THA Postop Pain

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