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

Assiut University

Status: Not yet enrolling

Conditions: Pain, Postoperative

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06410404

post-sternotomy pain control

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Levobupivacaine group

Active Comparator group

Description:

* 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.

Treatment:

Procedure: transversus thoracis plane block

Drug: Levobupivacaine

Combined levobupivacaine, and dexmeditomedine group

Active Comparator group

Description:

* 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.

Treatment:

Procedure: transversus thoracis plane block

Drug: Levobupivacaine

Drug: Dexmedetomidine