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

NCT06565910 | Recruiting Phase 4 DMC

• 1 other identifier: TJ-IRB202407066
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction?
2. 2.What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery?
3. 3.Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance.
4. 4.Undergo hip replacement surgery under spinal anesthesia.
5. 5.Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.

Conditions

Femoral Neck Fractures; Femur Head Necrosis; Hip Fractures

Keywords

Bupivacaine Liposome; PENG block; Hip Arthroplasty; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Overall Opioid Consumption

  This primary outcome entails tracking and assessing the total opioid consumption by participants following hip replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.

  this outcome will be monitored and recorded within 72 hours postoperatively

Secondary Outcomes (4)

• Pain intensity

  at multiple time points within 72 hours post-surgery.

• Time to First Rescue Analgesic

  72 hours after surgery.

• Incidence of Complications or Adverse Events

  90 days after the surgical procedure

• Duration of Hospital Stay

  through study completion, an average of 1 year

Study Arms (2)

Liposomal Bupivacaine plus Bupivacaine Intervention

EXPERIMENTAL

Participants in this arm will receive liposomal bupivacaine(LB) plus bupivacaine(B) as a local anesthetic for PENG block under ultrasound guidance. Liposomal bupivacaine plus bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of liposomal bupivacaine plus bupivacaine compared to the standard local anesthetic, ropivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery.

Drug: Liposomal bupivacaine plus bupivacaine

Ropivacaine Intervention

ACTIVE COMPARATOR

Participants in this arm will receive ropivacaine (R) as a local anesthetic for the PENG block under ultrasound guidance. Ropivacaine, a routinely used local anesthetic in clinical practice, is being compared to liposomal bupivacaine plus bupivacaine to assess its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of ropivacaine in comparison to the investigational intervention, liposomal bupivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery.

Drug: Ropivacaine

Interventions

Liposomal bupivacaine plus bupivacaine DRUG

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.

Also known as: LB+B

Liposomal Bupivacaine plus Bupivacaine Intervention

Ropivacaine DRUG

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.

Also known as: R

Ropivacaine Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (6)

• Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Feldman LS, Steele SR. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017 Aug;60(8):761-784. doi: 10.1097/DCR.0000000000000883. No abstract available.

  PMID: 28682962 BACKGROUND

• Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242.

  PMID: 28445352 BACKGROUND

• Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

  PMID: 30877144 BACKGROUND

• Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.

  PMID: 30304509 BACKGROUND

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

• McCann ME. Liposomal Bupivacaine. Anesthesiology. 2021 Feb 1;134(2):139-142. doi: 10.1097/ALN.0000000000003658. No abstract available.

  PMID: 33433621 BACKGROUND

Related Links

• a description of liposomal bupivacaine: EXPAREL

MeSH Terms

Conditions

Femoral Neck Fractures; Femur Head Necrosis; Hip Fractures

Interventions

Bupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wei Mei, MD

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

  STUDY DIRECTOR

Central Study Contacts

Xijian KE, MD

CONTACT

13429826148; kexijian@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Given the distinct visual appearance of the liposomal bupivacaine (milky white) and ropivacaine (transparent), a double-blind study design is not feasible. Consequently, this study employs a single-blind approach where neither participants nor outcome assessors will be aware of treatment allocation. Healthcare providers administering the study drug will be aware of the treatment group assignment. Rigorous procedures will be implemented to minimize potential bias, including standardized outcome assessment tools, blinded data entry, and independent data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This study utilizes a parallel interventional design, where participants undergoing hip arthroplasty surgery will be allocated into two separate groups. One group will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for Pericapsular Nerve Group (PENG) block, while the other group will receive ropivacaine for the same purpose. Both interventions will be administered under ultrasound guidance. The study aims to compare the analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction between the two groups, with assessments conducted at multiple time points within 72 hours post-surgery. The parallel design allows for the direct comparison of the two interventions and their respective outcomes in managing postoperative pain following hip arthroplasty.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 22, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication.
• Access Criteria: The IPD and any additional supporting information will be shared with qualified researchers upon request. Access will be granted for the purpose of conducting further analyses related to the outcomes of the clinical trial, such as but not limited to, pain relief, opioid analgesic consumption, and complications. Requests for access will be reviewed by the principal investigators and designated research personnel to ensure that the proposed analyses align with the objectives of the study and maintain participant confidentiality. Access to the data will be provided through a secure mechanism that safeguards the privacy and integrity of the individual participant data.

Locations

CN (1)