Liposomal Bupivacaine and Bupivacaine for TTMPB in Median Sternotomy
ConditionMedian Sternotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-90 years;
ASA Class I ~ III;
Patients undergoing elective median sternotomy.
Disqualifiers
Emergency surgery;
Re-operation;
Coagulation dysfunction;
Preoperative left ventricular function was poor (ejection fraction <35%);
Trial design
Design model
Parallel
Treatments tested in this trial
Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture
Procedure/SurgeryLiposomal bupivacaine and bupivacaine mixture were used for transverse thoracic muscle plane block (TTMPB) in experimental group.
Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride
Procedure/SurgeryBupivacaine hydrochloride was used for transverse thoracic muscle plane block (TTMPB) in active control group.
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: Mixture of liposome bupivacaine and bupivacaine hydrochlorideExperimental treatment 1 intervention
Group B: Bupivacaine hydrochloride aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Third-day opioid consumption
Opioid consumption was converted to Milligram morphine equivalent (MME) using the analgesic Drug Equivalence calculator.
Time frame
48-72 hours after surgerySecondary outcomes
1
Cumulative opioid consumption 72 hours after surgery
Opioid consumption was converted to Milligram morphine equivalent (MME) using the analgesic Drug Equivalence calculator.
Time frame
0-72 hours after surgery2
Numerical rating scales, NRS
Numerical rating scales, NRS: 0-10 A score of 0 is reported as completely painless, and a score of 10 is reported as the most intolerable pain.
Time frame
24 hours, 48 hours and 72 hours after surgery3
Sensory block resolution time
Time of resolution of numbness in the sternum skin.
Time frame
0-72 hours after surgery4
Consumption of acetaminophen
Acetaminophen requirement after surgery.
Time frame
0-72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov