Comparison of Liposomal Bupivacaine Versus Ropivacaine in Alleviating Rebound Pain

NCT07196631 | Active Not Recruiting Phase 4

• 1 other identifier: TJMZK202507
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder arthroscopy is a frequently performed orthopedic procedure used to address various issues like rotator cuff tears, instability, and stiffness. However，postoperative pain is a common complaint, effective postoperative pain management is a crucial component to recovery after shoulder arthroscopy. For pain control after arthroscopic shoulder surgery, the interscalene brachial plexus block (IBP) is often regarded as the gold standard. It is easy to perform and has limited side effects. Nonetheless, the pain-relieving effects of the block usually last for less than 24 hours, even when using long-lasting local anesthetics like bupivacaine and ropivacaine. Considerable rebound pain is an important limitations of nerve block against postoperative pain.Its incidence is reported to be between 35% and 62% , and is more common after bone and joint surgeries, especially those involving the shoulder and knee, with a frequency 1.8 times greater than that of soft tissue operations . Therefore, it is essential to establish effective measures to avert its occurrence.Liposomal bupivacaine with its multivesicular formulation, is designed to facilitate the sustained and controlled release of bupivacaine. This formulation extended the duration of anesthetic effect and minimized rebound pain. However, studies on liposomal bupivacaine for peripheral nerve blockade have engendered great controversy. Numerous researches suggested that the use of liposomal bupivacaine for shoulder surgeries is comparable to conventional local anesthetics in terms of overall pain relief, opioids consumption, hospital stays, and postoperative complications. In this study, a randomized controlled trial with blinding of patients and outcome assessors was conducted to determine whether liposomal bupivacaine in the interscalene brachial plexus block would improve rebound pain compared to ropivacaine in patients undergoing arthroscopic shoulder surgery.

Conditions

Rebound Pain; Liposomal Bupivacaine

Keywords

rebound pain; Shoulder Arthroscopy; liposomal bupivacaine; ropivacaine

Outcome Measures

Primary Outcomes (1)

• incidence of rebound pain in two groups.

  Rebound pain (RP) was defined as the abrupt transition from well-controlled pain (Numerical Rating Scale, NRS ≤ 3) during the effective period of the block to severe pain (NRS ≥ 7) within 24 hours of block performance

  up to 24 hours

Secondary Outcomes (8)

• the weighted area under the curve (AUC) for resting Numeric Rating Scale pain scores over the first 24 hours postoperatively

  day 1

• the initial onset time of pain during 72 hours

  up to 72 hours

• the Numeric Rating Scale pain score of initial pain happened

  up to 72 hours

• the Numeric Rating Scale pain scores at 48 and 72 hours postoperatively

  at 48 and 72 hours

• the duration of movement recovery

  up to 72 hours

Study Arms (2)

group LBP

EXPERIMENTAL

patients randomized to the intervention arm received 133mg of liposomal bupivacaine

Drug: Liposomal Bupivicaine

group RP

ACTIVE COMPARATOR

those in the control group received 80mg of ropivacaine

Drug: ropivacaine

Interventions

Liposomal Bupivicaine DRUG

patients randomized to the intervention arm received 133mg of liposomal bupivacaine

Also known as: Ai Heng Ping

group LBP

ropivacaine DRUG

those in the control group received 80mg of ropivacaine

Also known as: Di Shi Li

group RP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults between 18 and 65 year-old
• American Society of Anesthesiologist (ASA) grades 1 to 3 physical classification status
• patients unilateral primary arthroscopic shoulder surgery lasting 1to 4 hours

You may not qualify if:

• had an allergy or intolerance to amide-type local anesthetics
• objective evidence of nerve damage in the affected upper limb
• local infection
• impaired renal function (defined as effective glomerular filtration rate \< 30ml/min/1.73m2)
• coagulation disorders
• respiratory compromise（requires long term oxygen）
• had participated in another research trial involving an investigational medicinal product in the 6 months before randomization

Sponsors & Collaborators

• Liu Jiuhong: lead

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jiuhong Liu

  Tongji Hospital, Tongji medical college, Huazhong University of Science and Techonology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and outcome assessors were blinded to group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 29, 2025
• Study Start: September 20, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 5, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)