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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

668 Participants
are divided into 2 treatment groups
Group A: liposomal bupivacaineExperimental treatment 1 intervention
Group B: normal salinePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
the first 24 hours after surgery

Secondary outcomes

1

Area under the pain intensity-time curve

Area under the pain intensity-time curve (0-72 hours) at rest / with movement

Time frame
up to 72 hours
2

Total postoperative opioid consumption

Total postoperative opioid consumption (IV morphine mg equivalents) at 24, 48, and 72 hours

Time frame
24, 48, 72 hours

Other outcomes

Sponsors and contacts

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