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

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Fentanyl infusion; Procedure: Ultrasound guided TAP block; Drug: Dexmedetomidine

• Registration Number: NCT03393988
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2017-12-23
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Study First Posted: 2018-01-09
• Last Update Posted: 2018-01-09
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• American Society of Anesthesia (ASA) physical status I or II
• Scheduled as live liver donors
• J-shaped incision in the supraumblical region

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group F	Fentanyl infusion	Fentanyl infusion (0.5 µg/kg/hr)
Group (TAP-Dex)	Fentanyl infusion	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).
Group (TAP-Dex)	Ultrasound guided TAP block	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).
Group (TAP-Dex)	Dexmedetomidine	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).

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption	Intraoperative	Total Intravenous fentanyl consumption during the operation

Secondary Outcome Measures

Name	Time	Method
Average sevoflurane concentration	Intraoperative	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)
The severity of postoperative nausea and vomiting (PONV)	First 24 hours postoperatively	Will be recorded and classified as "no PONV, mild PONV, moderate PONV and severe PONV"
Ramsay sedation score (RSS)	First 24 hours postoperatively	Will be used for assessment of sedation immediately after extubation, after 2 hours of ICU admission, after 12 hours then after 24 hours .

Trial Locations

Locations (1)

Hospitals of Faculty of Medicine , Ain Shams University; 🇪🇬 Cairo, Egypt