About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
18-65 years old;
ASA Physical Status 1-3;
Scheduled for elective unilateral orthopedic surgery of the upper or lower extremity.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
liposomal bupivacaine
DrugPrepare 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
DrugPrepare a local anesthetic by combining normal saline (10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Area under the pain intensity-time curve
Area under the pain intensity-time curve (0-72 hours) at rest / with movement
Total postoperative opioid consumption
Total postoperative opioid consumption (IV morphine mg equivalents) at 24, 48, and 72 hours
Sponsors and contacts
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