Ireland
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Starting soon Phase 4

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

NCT07606911 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-10-01
Last updated
2026-09-02

Condition(s) studied

Acute PainOrthopaedic Surgery

Investigational drug(s) / intervention(s)

liposomal bupivacaine →Normal Saline

liposomal bupivacaine: 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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 18-65 years old; * ASA Physical Status 1-3; * Scheduled for elective unilateral orthopedic surgery of the upper or lower extremity. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • incidence of rebound pain — the first 24 hours after surgery
    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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai sixth people's hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07606911 on ClinicalTrials.gov ↗ ← All trials in China