Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT06410404
- Lead Sponsor
- Assiut University
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Adult patients > 20 years old.
- ASA II to III patients undergoing elective cardiac surgery via a median sternotomy
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levobupivacaine group transversus thoracis plane block * 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 transversus thoracis plane block * 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. Combined levobupivacaine, and dexmeditomedine group 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. Levobupivacaine group 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 Dexmedetomidine * 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.
- Primary Outcome Measures
Name Time Method Total post-operative morphine consumption. 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.
- Secondary Outcome Measures
Name Time Method Post-operative pain score 24 hours post-operative 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.
Intensive Care Unit (ICU) stay length. 4 days time till discharge from the ICU
Complications of the interventional block 24 hours post-operative * Pneumothorax.
* Hemothorax.
* Local anaesthetic systemic toxicity.
* Intravascular injection.
* Allergy to the local anaesthetic used.
* Infection.
* Hematoma.
* Neural injury.
* Damage to internal thoracic artery.Time till request of first analgesia. 24 hours post-operative 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.