Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery.

NCT07606911 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: BLOC trialGrant No. 20240814Grant No. 82525022
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

Brief Summary

This study will prospectively compare the preventive effect of liposomal bupivacaine combined with plain bupivacaine versus plain bupivacaine alone on rebound pain after nerve block in patients undergoing orthopedic extremity surgery. The primary aim is to assess whether the combination reduces the incidence or severity of rebound pain (i.e., more effectively covers the postoperative inflammatory peak on days 2-3 and provides a smoother regression curve of sensory blockade). Secondary aims include evaluation of upper limb functional scores, occurrence of chronic pain, and health-related quality of life. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.

Conditions

Acute Pain; Orthopaedic Surgery

Outcome Measures

Primary Outcomes (1)

• incidence of rebound pain

  Rebound pain was defined as initial mild pain (\<4/ 10) when the patient left the recovery room, progressing to severe pain (\>7/10) (NRS, 0-10) occurring within the first 24 hours after the procedure.

  the first 24 hours after surgery

Secondary Outcomes (2)

• Area under the pain intensity-time curve

  up to 72 hours

• Total postoperative opioid consumption

  24, 48, 72 hours

Study Arms (2)

liposomal bupivacaine

EXPERIMENTAL

5 ml of plain bupivacaine 0.75% will be mixed with 10 ml liposomal bupivacaine (133mg)

Drug: liposomal bupivacaine

normal saline

PLACEBO COMPARATOR

5 ml of plain bupivacaine 0.75% will be combined with 10 ml of normal saline

Drug: Normal Saline

Interventions

liposomal bupivacaine DRUG

Prepare a local anesthetic by combining liposomal bupivacaine (133 mg/10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.

liposomal bupivacaine

Normal Saline DRUG

Prepare a local anesthetic by combining normal saline (10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.

normal saline

Eligibility Criteria

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

You may qualify if:

• years old;
• ASA Physical Status 1-3;
• Scheduled for elective unilateral orthopedic surgery of the upper or lower extremity.

You may not qualify if:

• Women who are pregnant or breastfeeding;
• Bupivacaine sensitivity or known allergy;
• Contraindication for nerve blocks;
• Enrollment in another clinical trial that could confound pain evaluation;
• Other conditions that preclude study participation.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai sixth people's hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

CN (1)