Liposomal Bupivacaine and Bupivacaine for TTMPB in Median Sternotomy

NCT06646172 | Recruiting

• 1 other identifier: Tongji Hospital102114-3
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

In light of the ongoing controversy surrounding the efficacy of bupivacaine liposomes, our study was designed to investigate, for the first time, the differential postoperative analgesic effects between bupivacaine liposomes combined with bupivacaine hydrochloride and bupivacaine hydrochloride alone in transverse thoracic muscle plane block treatment. The aim is to provide evidence-based medical guidance for drug selection in regional block local anesthesia.

Conditions

Median Sternotomy

Outcome Measures

Primary Outcomes (1)

• Third-day opioid consumption

  Opioid consumption was converted to Milligram morphine equivalent (MME) using the analgesic Drug Equivalence calculator.

  48-72 hours after surgery

Secondary Outcomes (7)

• Cumulative opioid consumption 72 hours after surgery

  0-72 hours after surgery

• Numerical rating scales, NRS

  24 hours, 48 hours and 72 hours after surgery

• Sensory block resolution time

  0-72 hours after surgery

• Consumption of acetaminophen

  0-72 hours after surgery

• Consumption of rescue opioid administration

  0-72 hours after surgery

Study Arms (2)

Mixture of liposome bupivacaine and bupivacaine hydrochloride

EXPERIMENTAL

The same anesthesiologist with experience in regional block was used for ultrasound guided bilateral transverse thoracic muscle plane block (T4-5 interstital space, paracentral transverse axis position). According to the literature, in this study, 1.33% bupivacaine liposome 10 mL + 0.5% bupivacaine hydrochloride 10 ml was used.

Procedure: Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture

Bupivacaine hydrochloride alone

ACTIVE COMPARATOR

The same anesthesiologist with experience in regional block was used for ultrasound guided bilateral transverse thoracic muscle plane block (T4-5 interstital space, paracentral transverse axis position). According to the literature, in this study, 0.5% bupivacaine 20ml was used.

Procedure: Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride

Interventions

Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture PROCEDURE

Liposomal bupivacaine and bupivacaine mixture were used for transverse thoracic muscle plane block (TTMPB) in experimental group.

Mixture of liposome bupivacaine and bupivacaine hydrochloride

Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride PROCEDURE

Bupivacaine hydrochloride was used for transverse thoracic muscle plane block (TTMPB) in active control group.

Bupivacaine hydrochloride alone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-90 years;
• ASA Class I \~ III;
• Patients undergoing elective median sternotomy.

You may not qualify if:

• Emergency surgery;
• Re-operation;
• Coagulation dysfunction;
• Preoperative left ventricular function was poor (ejection fraction \<35%);
• Systemic infection or injection site infection;
• Neuromuscular diseases;
• Mental illness;
• Dependence on psychotropic drugs;
• Allergic to bupivacaine liposomes and bupivacaine;
• Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization;
• Failure to obtain written informed consent from the patient or his/her representative

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tianzhu Liu

Wuhan, Hubei, 430000, China

RECRUITING

Study Officials

• Mei Wei, M.D.

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Liu Tianzhu, M.D.

CONTACT

13098866448; liutzh@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 17, 2024
• Study Start: October 24, 2024
• Primary Completion: October 24, 2024
• Study Completion (Estimated): October 12, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)