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

NCT06410404 | Not Yet Recruiting DMC

• 1 other identifier: post-sternotomy pain control
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Post-operative pain score

  24 hours post-operative

• Time till request of first analgesia.

  24 hours post-operative

• Intensive Care Unit (ICU) stay length.

  4 days

• Complications of the interventional block

  24 hours post-operative

Study Arms (2)

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.

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.

Procedure: transversus thoracis plane block; Drug: Dexmedetomidine; Drug: Levobupivacaine

Interventions

transversus thoracis plane block PROCEDURE

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.

Also known as: TTPB

Combined levobupivacaine, and dexmeditomedine group; Levobupivacaine group

Dexmedetomidine DRUG

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

Combined levobupivacaine, and dexmeditomedine group

Levobupivacaine DRUG

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

Combined levobupivacaine, and dexmeditomedine group; Levobupivacaine group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \> 20 years old.
• ASA II to III patients undergoing elective cardiac surgery via a median sternotomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• 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.

  PMID: 21955825 BACKGROUND

• 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.

  PMID: 31504913 BACKGROUND

• 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.

  PMID: 17312231 BACKGROUND

• 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.

  PMID: 18936379 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 23132359 BACKGROUND

• 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.

  PMID: 25796483 BACKGROUND

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

  PMID: 30861264 BACKGROUND

• 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.

  PMID: 26079353 BACKGROUND

• 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.

  PMID: 36511495 BACKGROUND

• 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.

  PMID: 32665179 BACKGROUND

• 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.

  PMID: 34803399 BACKGROUND

• 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.

  PMID: 37220544 BACKGROUND

Related 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/

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ahmed W Shamsedine, Assistant lecturer

CONTACT

01148899869; ahmedwahby777@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 13, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05