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PENG Block Versus LP Block for THA Postop Pain

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ClinicalTrials.gov Identifier: NCT05261009
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Hip Pain Chronic Drug: Peri-capsular Nerve Group (PENG) Other: Lumbar Plexus Block (LPB) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: PENG Block Versus LP Block for Postoperative Analgesia After Anterior Total Hip
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Numeric Rating Scale (NRS) Pain Score [ Time Frame: hour 6 ]
    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 :
  1. NRS Pain Score [ Time Frame: hour 12 ]
    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.

  2. NRS Pain Score [ Time Frame: hour 18 ]
    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.

  3. NRS Pain Score [ Time Frame: hour 24 ]
    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.

  4. Opioid administration [ Time Frame: hour 24 ]
    Average time to first dose of opioid rescue for postoperative pain management

  5. Motor strength [ Time Frame: hour 6 ]
    straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement

  6. Distance Ambulated [ Time Frame: hour 24 ]
    Recorded in feet during first physical therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05261009


Contacts
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Contact: Rawad Hamzi, MD 336-716-4498 rhamzi@wakehealth.edu
Contact: Lynnette Harris, BSN 336-716-8791 lcharris@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rawad Hamzi, MD    336-716-4498    rhamzi@wakehealth.edu   
Contact: Lynnette Harris, BSN    336-716-8791    lcharris@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Rawad Hamzi, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT05261009    
Other Study ID Numbers: IRB00078699
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations