Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries

Pain, Postoperative Clinical Trial

Official title:

Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410404
• Other study ID #: post-sternotomy pain control
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Ahmed W Shamsedine, Assistant lecturer
• Phone: 01148899869
• Email: ahmedwahby777[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult patients > 20 years old.

• ASA II to III patients undergoing elective cardiac surgery via a median sternotomy

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• transversus thoracis plane block
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.

Drug:
• Dexmedetomidine
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
• Levobupivacaine
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

Aydin 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. — View Citation

Chen 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. — View Citation

El-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. — View Citation

Huang 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. — View Citation

Kehlet 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. — View Citation

Liu 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. — View Citation

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. — View Citation

Moon 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. — View Citation

Popping 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. — View Citation

Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626. — View Citation

Shokri 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. — View Citation

Ueshima 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. — View Citation

Walian 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours post-operative
Secondary	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.	24 hours post-operative
Secondary	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.	24 hours post-operative
Secondary	Intensive Care Unit (ICU) stay length.	time till discharge from the ICU	4 days
Secondary	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.	24 hours post-operative

External Links

•   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/