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Median SternotomyNCT06646172

Liposomal Bupivacaine and Bupivacaine for TTMPB in Median Sternotomy

A study testing Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture and Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride in people with Median Sternotomy, run by Tongji Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Median Sternotomy
What is being tested?
Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture and Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
24 Oct 2024to 12 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Emergency surgery;
  • Re-operation;
  • Coagulation dysfunction;
  • Preoperative left ventricular function was poor (ejection fraction <35%);
  • Systemic infection or injection site infection;
  • Neuromuscular diseases;
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Liu Tianzhu, M.D. contact

13098866448

liutzh@126.com

China1 site, 1 recruiting
  • Tianzhu Liu

    Wuhan, Hubei, 430000

    Tianzhu, M.D., 13098866448, liutzh@126.com

    Tianzhu Liu, M.D., 13098866448, liutzh@126.com

    Recruiting

Other trials in China

About this study

Official title: Liposomal Bupivacaine and Bupivacaine Alone Transverse Thoracic Muscle Plane Blocks in Median Sternotomy: a Prospective, Single-blind, Randomized Controlled Study

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.

Read the detailed description

Median thoracic incision is a common method in cardiac surgery for valve replacement, coronary artery bypass and large vessel reconstruction. This kind of surgery is generally more traumatic, with obvious pain stimulation and intense stress response. Compared with other types of surgery, thoracotomy often requires larger doses of opioid analgesics, but excessive use of perioperative opioids has significant adverse effects on postoperative recovery, including sedation, constipation, nausea, addiction and respiratory depression. In addition, improper management of perioperative acute pain during thoracotomy may turn into chronic pain, which will seriously affect patients' postoperative quality of life. For pain management in thoracotomy surgery, the previous practice was to use thoracic epidural continuous catheterization to perform intradural block, but due to the narrow vertebral space in the thoracic vertebrae, this technique is difficult to operate, and for cardiac surgery, individual heparinization requirements of extracorporeal circulation during the operation may greatly increase the possibility of epidural catheter hematoma. Other studies have shown that thoracic epidural block may further lead to sympathetic block, which increases the complexity of perioperative hemodynamic management and concerns the possibility of cerebrovascular accidents.

Transversus Thoracic Plane block (TTP) is a relatively new fascial plane block method. Ultrasound visualization guidance significantly improved the safety of transversus thoracic plane block, and precise injection of local anesthesia drugs could provide perfect analgesia for the anterior branches of the second to sixth intercostal nerves. At the same time, the dosage of other analgesic drugs including opioids can be reduced to reduce the occurrence of related complications [9, 10]. Compared with multimodal analgesia alone, transverse thoracic muscle plane block can significantly reduce postoperative opioid dose. Unlike paravertebral block, the target of the transverse thoracic plane block is the distal branch of the anterior spinal nerve, so there is no risk of sympathetic block, and the injection site is far from the foramen, and there is no risk of intraspinal block or general spinal anesthesia. In view of its high effectiveness and safety, it has been successfully applied in adults and children with median thoracotomy and achieved good perioperative analgesic effects. According to the literature, the transverse thoracic plane block can also be used for the analgesic management of sternal fracture, rib fracture, sternotomy, chronic pain, and the medial incision of breast surgery.

Long-acting amide local anesthetics have been used for surgical incision infiltration anesthesia and shoulder intermuscular groove regional block anesthesia. Although bupivacaine can meet the regional anesthesia requirements for most surgeries, bupivacaine is more likely to cause serious cardiotoxicity when given the same dose as ropivacaine. Bupivacaine and ropivacaine, commonly used local anesthetics for regional block, are similar in terms of sensory action, duration, and blocking effect, but Ropivacaine has greater sensory-motor selectivity, less central nervous system and cardiac toxicity, wider safe dose range, lower reinforcement effect, and longer motor block duration. Therefore, in the current domestic regional block anesthesia technology, the application of both in regional block is more extensive.

Liposomal bupivacaine is a long-acting local anesthetic drug prepared by liposomal technology with slow-release characteristics. It has been reported that the action time of a single administration of bupivacaine liposomal is as high as 72 hours. The drug was approved by the U.S. Food and Drug Administration in October 2011 for postoperative pain management and in April 2018 for nerve block producing regional anesthesia. Compared with bupivacaine, most current research results suggest that the blocking effect of bupivacaine liposomes is not significantly superior to that of standard bupivacaine. However, other studies have suggested that bupivacaine liposomes have a significant advantage in reducing early postoperative opioid use. A non-inferior study of bupivacaine liposome and bupivacaine hydrochloride combined with bupivacaine hydrochloride intermuscular brachial plexus block in patients with total shoulder arthroplasty by Neil A Hanson et al. found that although there was a statistically significant reduction in opioid use on day 3 after surgery, However, the cumulative use of opioids in the bupivacaine hydrochloride group within 3 days after surgery did not show significant inferiority.

Being tested
Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture, Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixtureProcedure or surgery

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

  • Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochlorideProcedure or surgery

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

Study groups in NCT06646172
Study groupRoleWhat they receive
Mixture of liposome bupivacaine and bupivacaine hydrochlorideExperimentalThe 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.
Receives: Procedure: Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture
Bupivacaine hydrochloride aloneActive comparatorThe 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.
Receives: Procedure: Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Third-day opioid consumption

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

    Measured: 48-72 hours after surgery

Secondary outcomes (7)
  1. Cumulative opioid consumption 72 hours after surgery

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

    Measured: 0-72 hours after surgery

  2. 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.

    Measured: 24 hours, 48 hours and 72 hours after surgery

  3. Sensory block resolution time

    Time of resolution of numbness in the sternum skin.

    Measured: 0-72 hours after surgery

  4. Consumption of acetaminophen

    Acetaminophen requirement after surgery.

    Measured: 0-72 hours after surgery

  5. Consumption of rescue opioid administration

    Rescue opioid is administrated if the NRS > 4

    Measured: 0-72 hours after surgery

  6. Patient satisfaction

    Patient satisfaction with postoperative pain management. (0-5, 0 is very dissatisfied and 5 is very satisfied)

    Measured: 0-72 hours during and after surgery

  7. Adverse reactions

    Adverse reactions related to block procedure.

    Measured: 0-72 hours during and after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study start24 Oct 2024
  3. Primary completion24 Oct 2024
  4. Study completion12 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06646172
Sponsor's protocol ID
Tongji Hospital102114-3
Status last verified
Oct 2024
First submitted
12 Oct 2024
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture and Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride in people with Median Sternotomy, run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liu Tianzhu, M.D. (13098866448, liutzh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Third-day opioid consumption (time frame: 48-72 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.

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