Pain, PostoperativeNCT06410404
Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries
A study testing transversus thoracis plane block, Dexmedetomidine and Levobupivacaine in people with Pain, Postoperative, run by Assiut University.
Trial summary
the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- transversus thoracis plane block, Dexmedetomidine and Levobupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Jul 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 20 years old.
- ASA II to III patients undergoing elective cardiac surgery via a median sternotomy
Who cannot join
- Patient's refusal.
- Known contraindications to regional blocks, including local skin infections,and coagulopathy.
- Allergies to the local anaesthetics used.
- Patients undergoing complex cardiac procedures.
- Patients with severe chronic obstructive pulmonary disease.
- Patients unable to communicate.
- Patients with chronic pain.
- Patients with severe pulmonary hypertension.
Trial locations and contacts
No sites are listed yet.
About this study
the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain.
Read the detailed description
the patients will fall into one of two groups using an online randomizer. this study is an assessor-blinded interventional controlled study. the first group will recieve transversus thoracis plane block bilaterally where 15 ml of 0.25% levobupivacaine will be given. and the other group shall also undergo a bilateral transversus thoracis plane block with 15 ml 0.25% levobupivacaine and 0.05 ug/kg dexmeditomedine on each side. the primary aim of the study is the 24 hour post-operative morphine consumption.
- Conditions
- Pain, Postoperative
- Being tested
- transversus thoracis plane block, Dexmedetomidine, Levobupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus thoracis plane blockProcedure or surgery
Also called TTPB
with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, different drugs according to the different groups will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
DexmedetomidineDrug
the dexmeditomedine group shall undergo bilateral transversus thoracis plane block with 15 ml of 25% levobupivacaine, and 0.05 ug/kg dexmeditomedine on each side of the sternum
LevobupivacaineDrug
A local anesthetic that will be instilled in the transversus thoracic plane in a dose of 15 ml of a 25% concentration on both sides of the sternum in both groups
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine group | Active comparator | * Patients in this group shall receive levobupivacaine alone.
* Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle. Receives: Procedure: transversus thoracis plane block; Drug: Levobupivacaine |
| Combined levobupivacaine, and dexmeditomedine group | Active comparator | * Patients in this group shall receive levobupivaciane in addition to dexmeditomedine as an adjuvant.
* Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25%, together with dexmeditomedine in a dose of 1 ug/kg will be injected between the transversus thoracic muscle and the internal intercosatal muscle. Receives: Procedure: transversus thoracis plane block; Drug: Dexmedetomidine; Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total post-operative morphine consumption.
If the patient experiences a pain of > 4, he will be given morphine intravenously in a dose of 0.05 mg/kg IV by a blinded assessor, aiming for a pain score of ≤ 4. The total morphine dose for the post-operative 24 hours will be compared between the case and control group, to determine which technique provided more analgesia.
Measured: 24 hours post-operative
Secondary outcomes (4)
Post-operative pain score
VAS (Visual Analogue Scale, 0-10; where 0 = no pain, and 10 = worst imaginable pain) will be assessed at rest, preoperatively, half an hour after extubation, and at 4th, 8th, 12th, 16th, 20th, and 24th hours post operatively. Moreover, VAS will also be assessed at 12th and 24 hours post-operatively while coughing.
Measured: 24 hours post-operative
Time till request of first analgesia.
comparison of the time till request of first analgesia difference between the two groups, shall give us a clue to the effect of demeditomedine on the duration of the pain controlling effect of the used block.
Measured: 24 hours post-operative
Intensive Care Unit (ICU) stay length.
time till discharge from the ICU
Measured: 4 days
Complications of the interventional block
- Pneumothorax.
- Hemothorax.
- Local anaesthetic systemic toxicity.
- Intravascular injection.
- Allergy to the local anaesthetic used.
- Infection.
- Hematoma.
- Neural injury.
- Damage to internal thoracic artery.
Measured: 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed wahby Shamsedine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410404
- Sponsor's protocol ID
- post-sternotomy pain control
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the decision shall be taken at the end of the study. I anticipate that it is going to be a "yes".
Publications
Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
PubMed 21955825El-Ansary D, LaPier TK, Adams J, Gach R, Triano S, Katijjahbe MA, Hirschhorn AD, Mungovan SF, Lotshaw A, Cahalin LP. An Evidence-Based Perspective on Movement and Activity Following Median Sternotomy. Phys Ther. 2019 Dec 16;99(12):1587-1601. doi: 10.1093/ptj/pzz126.
PubMed 31504913Liu SS, Wu CL. Effect of postoperative analgesia on major postoperative complications: a systematic update of the evidence. Anesth Analg. 2007 Mar;104(3):689-702. doi: 10.1213/01.ane.0000255040.71600.41.
PubMed 17312231Popping DM, Elia N, Marret E, Remy C, Tramer MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008 Oct;143(10):990-9; discussion 1000. doi: 10.1001/archsurg.143.10.990.
PubMed 18936379Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Moon MH, Kang JK, Kim HW, Jo KH, Choi SH, Song H. Pain after median sternotomy: collateral damage or mitigatable byproduct? Thorac Cardiovasc Surg. 2013 Apr;61(3):194-201. doi: 10.1055/s-0032-1311540. Epub 2012 Nov 6.
PubMed 23132359Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
PubMed 25796483Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626.
PubMed 30861264Ueshima H, Kitamura A. Blocking of Multiple Anterior Branches of Intercostal Nerves (Th2-6) Using a Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388. doi: 10.1097/AAP.0000000000000245. No abstract available.
PubMed 26079353Walian A, Magoon R, Shri I, Kashav RC. Transversus Thoracic Muscle Plane Block for Attenuating the Haemodynamic Response to Median Sternotomy: A Case Series. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):449-453. doi: 10.5152/TJAR.2022.21196.
PubMed 36511495Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
PubMed 32665179Shokri H, Ali I, Kasem AA. Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Post-Sternotomy Pain: A Randomized Controlled Trial. Local Reg Anesth. 2021 Nov 12;14:145-152. doi: 10.2147/LRA.S338685. eCollection 2021.
PubMed 34803399Chen Z, Liu Z, Feng C, Jin Y, Zhao X. Dexmedetomidine as an Adjuvant in Peripheral Nerve Block. Drug Des Devel Ther. 2023 May 17;17:1463-1484. doi: 10.2147/DDDT.S405294. eCollection 2023.
PubMed 37220544
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries
- ClinicalTrials.gov ID
- NCT06410404
- Acronym / sponsor ID
- post-sternotomy pain control
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 13 May 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.
the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain.
Detailed description
the patients will fall into one of two groups using an online randomizer. this study is an assessor-blinded interventional controlled study. the first group will recieve transversus thoracis plane block bilaterally where 15 ml of 0.25% levobupivacaine will be given. and the other group shall also undergo a bilateral transversus thoracis plane block with 15 ml 0.25% levobupivacaine and 0.05 ug/kg dexmeditomedine on each side. the primary aim of the study is the 24 hour post-operative morphine consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine group | Active comparator | Procedure: transversus thoracis plane block, Drug: Levobupivacaine* Patients in this group shall receive levobupivacaine alone. * Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle. |
| Combined levobupivacaine, and dexmeditomedine group | Active comparator | Procedure: transversus thoracis plane block, Drug: Dexmedetomidine, Drug: Levobupivacaine* Patients in this group shall receive levobupivaciane in addition to dexmeditomedine as an adjuvant. * Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of levobupivacaine 0.25%, together with dexmeditomedine in a dose of 1 ug/kg will be injected between the transversus thoracic muscle and the internal intercosatal muscle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients > 20 years old.
- ASA II to III patients undergoing elective cardiac surgery via a median sternotomy
Key exclusion criteria (8 listed)
- Patient's refusal.
- Known contraindications to regional blocks, including local skin infections,and coagulopathy.
- Allergies to the local anaesthetics used.
- Patients undergoing complex cardiac procedures.
- Patients with severe chronic obstructive pulmonary disease.
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 |
|---|---|---|
| transversus thoracis plane blockAlso: TTPBwith the patient lying in the supine position. After skin disinfection, a high frequency linear ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, different drugs according to the different groups will be injected between the transversus thoracic muscle and the internal intercosatal muscle. | Procedure or surgery | Combined levobupivacaine, and dexmeditomedine group, Levobupivacaine group |
| Dexmedetomidinethe dexmeditomedine group shall undergo bilateral transversus thoracis plane block with 15 ml of 25% levobupivacaine, and 0.05 ug/kg dexmeditomedine on each side of the sternum | Drug | Combined levobupivacaine, and dexmeditomedine group |
| LevobupivacaineA local anesthetic that will be instilled in the transversus thoracic plane in a dose of 15 ml of a 25% concentration on both sides of the sternum in both groups | Drug | Combined levobupivacaine, and dexmeditomedine group, Levobupivacaine group |
Primary outcome
Total post-operative morphine consumption.
Time frame: 24 hours post-operative
If the patient experiences a pain of > 4, he will be given morphine intravenously in a dose of 0.05 mg/kg IV by a blinded assessor, aiming for a pain score of ≤ 4. The total morphine dose for the post-operative 24 hours will be compared between the case and control group, to determine which technique provided more analgesia.
4 secondary outcomes
Post-operative pain score
Time frame: 24 hours post-operative
Time till request of first analgesia.
Time frame: 24 hours post-operative
Intensive Care Unit (ICU) stay length.
Time frame: 4 days
Complications of the interventional block
Time frame: 24 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 21955825Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
- Background: PubMed 31504913El-Ansary D, LaPier TK, Adams J, Gach R, Triano S, Katijjahbe MA, Hirschhorn AD, Mungovan SF, Lotshaw A, Cahalin LP. An Evidence-Based Perspective on Movement and Activity Following Median Sternotomy. Phys Ther. 2019 Dec 16;99(12):1587-1601. doi: 10.1093/ptj/pzz126.
- Background: PubMed 17312231Liu SS, Wu CL. Effect of postoperative analgesia on major postoperative complications: a systematic update of the evidence. Anesth Analg. 2007 Mar;104(3):689-702. doi: 10.1213/01.ane.0000255040.71600.41.
- Background: PubMed 18936379Popping DM, Elia N, Marret E, Remy C, Tramer MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008 Oct;143(10):990-9; discussion 1000. doi: 10.1001/archsurg.143.10.990.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 23132359Moon MH, Kang JK, Kim HW, Jo KH, Choi SH, Song H. Pain after median sternotomy: collateral damage or mitigatable byproduct? Thorac Cardiovasc Surg. 2013 Apr;61(3):194-201. doi: 10.1055/s-0032-1311540. Epub 2012 Nov 6.
- Background: PubMed 25796483Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
- Background: PubMed 30861264Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626.
- Background: PubMed 26079353Ueshima H, Kitamura A. Blocking of Multiple Anterior Branches of Intercostal Nerves (Th2-6) Using a Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388. doi: 10.1097/AAP.0000000000000245. No abstract available.
- Background: PubMed 36511495Walian A, Magoon R, Shri I, Kashav RC. Transversus Thoracic Muscle Plane Block for Attenuating the Haemodynamic Response to Median Sternotomy: A Case Series. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):449-453. doi: 10.5152/TJAR.2022.21196.
- Background: PubMed 32665179Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
- Background: PubMed 34803399Shokri H, Ali I, Kasem AA. Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Post-Sternotomy Pain: A Randomized Controlled Trial. Local Reg Anesth. 2021 Nov 12;14:145-152. doi: 10.2147/LRA.S338685. eCollection 2021.
- Ball M, Falkson SR, Fakoya AO, et al. Anatomy, Angle of Louis. \[Updated 2023 Dec 10\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459336/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. the decision shall be taken at the end of the study. I anticipate that it is going to be a "yes".
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transversus thoracis plane block, Dexmedetomidine and Levobupivacaine in people with Pain, Postoperative, run by Assiut University.
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 2 inclusion and 8 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed W Shamsedine, Assistant lecturer (01148899869 ext. +2, ahmedwahby777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total post-operative morphine consumption. (time frame: 24 hours post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410404, which also lists 13 linked publications.
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 30 May 2024.