Health TrialsbyHealthPanel

Bupivacaine Liposome Versus Bupivacaine for Ultrasound-Guided Suprascapular Nerve Combined With Axillary Nerve Block in Analgesia After Arthroscopic Shoulder Surgery

ConditionsArthroscopic Shoulder SurgeryUltrasound Guided Nerve BlockBupivacaineSuprascapular Nerve BlockAxillary Nerve Block
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHuazhong University of Science and Technology

About this trial

This trial is designed to compare the post-operative analgesic efficacy and safety of liposomal bupivacaine versus plain bupivacaine when both are used for ultrasound-guided combined suprascapular and axillary nerve block in patients undergoing elective arthroscopic shoulder surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-60 years

ASA physical status I-II

Undergoing unilateral arthroscopic shoulder surgery

The Operative time between 1and 4 hours

Disqualifiers

Anticipated operative time < 1 h or > 4 h

Severe cardiopulmonary insufficiency

Hepatic or renal dysfunction

Coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A（ liposomal bupivacene）

    Drug

    In the experimental group, 15 mL of a mixture containing liposomal bupivacaine plus plain bupivacaine is deposited around each target nerve (20 mL liposomal bupivacene, 266 mg, combined with 10 mL 0.75 % plain bupivacaine, total 30 mL).

  • Group B（bupivacene）

    Drug

    The control group receives 15 mL of 0.25 % plain bupivacaine around each nerve. Unlike the clear solution of plain bupivacaine, liposomal bupivacaine has a distinctive milky-white appearance.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A (liposomal bupivacene）Experimental treatment 1 intervention
Group B: Group B（bupivacene）Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid consumption after surgery

The primary outcome entails tracking and assessing the total opioid consumption by participants following arthroscopic shoulder surgery. The consumption of Opioid via patient-controlled analgesia will be recorded within 72h postoperatively.

Time frame
The outcome will be monitored and recorded within 72 hours postoperatively.

Secondary outcomes

1

Analgesic efficacy after surgery

To compare the analgesic efficacy of liposomal bupivacaine versus plain bupivacaine when used in ultrasound-guided combined suprascapular and axillary nerve block for arthroscopic shoulder surgery, VAS pain scores will be recorded at several time points from 0 to 72h.

Time frame
The outcome will be monitored and recorded within 72 hours postoperatively
2

Operative time

Total duration of surgery from skin incision to skin closure, measured in minutes

Time frame
Intraoperative
3

Length of hospital stay

Duration of hospitalization from admission to discharge, measured in days

Time frame
Through study completion, up to 7 days
4

Incidence of Allergic Reactions

Mild allergic reactions including skin rash, pruritus, urticaria, or local injection site reactions, graded using CTCAE v5.0 criteria

Time frame
From first dose to 3 days postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: