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.
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.
China1 site, 1 recruiting
- Recruiting
Tianzhu Liu
Wuhan, Hubei, 430000
Tianzhu, M.D., 13098866448, liutzh@126.com
Tianzhu Liu, M.D., 13098866448, liutzh@126.com
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.
- Conditions
- Median Sternotomy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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
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
Sensory block resolution time
Time of resolution of numbness in the sternum skin.
Measured: 0-72 hours after surgery
Consumption of acetaminophen
Acetaminophen requirement after surgery.
Measured: 0-72 hours after surgery
Consumption of rescue opioid administration
Rescue opioid is administrated if the NRS > 4
Measured: 0-72 hours after surgery
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
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.
- First posted17 Oct 2024
- Study start24 Oct 2024
- Primary completion24 Oct 2024
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median SternotomyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianzhu Liu, Tongji Hospital
- Investigators
- Mei Wei, M.D., Study director, Tongji Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine and Bupivacaine Alone Transverse Thoracic Muscle Plane Blocks in Median Sternotomy: a Prospective, Single-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06646172
- Acronym / sponsor ID
- Tongji Hospital102114-3
- Conditions
- Median Sternotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixture of liposome bupivacaine and bupivacaine hydrochloride | Experimental | Procedure: Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixtureThe 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. |
| Bupivacaine hydrochloride alone | Active comparator | Procedure: Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochlorideThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-90 years;
- ASA Class I ~ III;
- Patients undergoing elective median sternotomy.
Key exclusion criteria (11 listed)
- Emergency surgery;
- Re-operation;
- Coagulation dysfunction;
- Preoperative left ventricular function was poor (ejection fraction <35%);
- Systemic infection or injection site infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixtureLiposomal bupivacaine and bupivacaine mixture were used for transverse thoracic muscle plane block (TTMPB) in experimental group. | Procedure or surgery | Mixture of liposome bupivacaine and bupivacaine hydrochloride |
| Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochlorideBupivacaine hydrochloride was used for transverse thoracic muscle plane block (TTMPB) in active control group. | Procedure or surgery | Bupivacaine hydrochloride alone |
Primary outcome
Third-day opioid consumption
Time frame: 48-72 hours after surgery
Opioid consumption was converted to Milligram morphine equivalent (MME) using the analgesic Drug Equivalence calculator.
7 secondary outcomes
Cumulative opioid consumption 72 hours after surgery
Time frame: 0-72 hours after surgery
Numerical rating scales, NRS
Time frame: 24 hours, 48 hours and 72 hours after surgery
Sensory block resolution time
Time frame: 0-72 hours after surgery
Consumption of acetaminophen
Time frame: 0-72 hours after surgery
Consumption of rescue opioid administration
Time frame: 0-72 hours after surgery
Patient satisfaction
Time frame: 0-72 hours during and after surgery
Adverse reactions
Time frame: 0-72 hours during and after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Wei, M.D. study director
Tongji Hospital
1 site in 1 country: see every site and its status.
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.