RecruitingPhase 4NCT06565910

Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)

Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for PENG Block on Post Operative Pain Management in Patients Undergoing Hip Arthroplasty: a Prospective, Randomized, Single Blind, Active Controlled Study


Sponsor

Huazhong University of Science and Technology

Enrollment

60 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are: 1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction? 2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery? Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery. Participants will: 1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance. 2. Undergo hip replacement surgery under spinal anesthesia. 3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • American Society of Anesthesiologists(ASA) I\~II
  • Normal coagulation
  • Clinical diagnosis of hip fracture

Exclusion Criteria2

  • Presence of severe systemic diseases or ASA grade III or higher
  • Allergy to amide local anesthetics

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Interventions

DRUGLiposomal bupivacaine plus bupivacaine

Liposomal bupivacaine is a prolonged-release formulation of the local anesthetic bupivacaine. This intervention involves the administration of liposomal bupivacaine plus bupivacaine as a local anesthetic for the pericapsular nerve group (PENG) block under ultrasound guidance. Liposomal bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This formulation is designed to provide extended pain relief as compared to conventional bupivacaine formulations.

DRUGRopivacaine

Ropivacaine is a commonly used local anesthetic in clinical practice, and it serves as the active comparator intervention in this study. Participants in the comparator arm will receive ropivacaine as a local anesthetic for the PENG block under ultrasound guidance.


Locations(1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, China

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NCT06565910


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