Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study

Study Overview
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Brief Summary
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This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.

Official Title
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A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Fentanyl infusion
* Procedure: Ultrasound guided TAP block
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesia (ASA) physical status I or II Scheduled as live liver donors J-shaped incision in the supraumblical region Exclusion Criteria: Patients with a history of psychiatric/neurological illness, Hypertensive patients, Morbidly obese patients, Pregnant and nursing women, Patients with known allergic reaction to any of the study medications, Patients on recent use of sedatives or analgesics, Patients with significant laboratory abnormalities

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group F<br>Fentanyl infusion (0.5 µg/kg/hr) | Drug: Fentanyl infusion<br>* After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).<br>* Other names: Opioid;|
| Active Comparator: Group (TAP-Dex)<br>Ultrasound guided TAP block and Dexmedetomidine Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline) Fentanyl infusion (0.5 µg/kg/hr). | Drug: Fentanyl infusion<br>* After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).<br>* Other names: Opioid;Procedure: Ultrasound guided TAP block<br>* After induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery.<br>* Other names: Regional anesthesia;Drug: Dexmedetomidine<br>* Dexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 μg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 μg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading)<br>* Other names: alpha 2 sympathomimetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fentanyl consumption | Total Intravenous fentanyl consumption during the operation | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average sevoflurane concentration | The average sevoflurane concentration (the average concentration (%) for the case will be determined from the vaporizer setting recorded in the anesthetic record per 5-minute interval) | Intraoperative | 
| The severity of postoperative nausea and vomiting (PONV) | Will be recorded and classified as no PONV, mild PONV, moderate PONV and severe PONV | First 24 hours postoperatively | 
| Ramsay sedation score (RSS) | Will be used for assessment of sedation immediately after extubation, after 2 hours of ICU admission, after 12 hours then after 24 hours . | First 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus abdominis plane block,, Dexmedetomidine, Fentanyl, Live liver donor, Liver transplantation