Clinical trial NCT06565910: Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Femoral Neck Fractures
Femur Head Necrosis
Hip Fractures
Keywords: Bupivacaine Liposome
PENG block
Hip Arthroplasty
Randomized Controlled Trial
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall Opioid Consumption
timeFrame: this outcome will be monitored and recorded within 72 hours postoperatively
Secondary outcomes:
measure: Pain intensity
timeFrame: at multiple time points within 72 hours post-surgery.
measure: Time to First Rescue Analgesic
timeFrame: 72 hours after surgery.
measure: Incidence of Complications or Adverse Events
timeFrame: 90 days after the surgical procedure
measure: Duration of Hospital Stay
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
state: Hubei
Study officials:
affiliation: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
name: Wei Mei, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: McCann ME. Liposomal Bupivacaine. Anesthesiology. 2021 Feb 1;134(2):139-142. doi: 10.1097/ALN.0000000000003658. No abstract available.