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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Fentanyl infusion; Procedure: Ultrasound guided TAP block; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Hospitals of Faculty of Medicine , Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group F; Fentanyl infusion (0.5 µg/kg/hr)	Drug: Fentanyl infusion; 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).; Other Names: Opioid
Active Comparator: Group (TAP-Dex); 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; 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).; Other Names: Opioid; Procedure: Ultrasound guided TAP block; 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.; Other Names: Regional anesthesia; Drug: Dexmedetomidine; 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); Other Names: alpha 2 sympathomimetic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Liver transplantation; Fentanyl; Dexmedetomidine; Transversus abdominis plane block,; Live liver donor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine; Sympathomimetics
• Other Study ID Numbers: FMASU R45/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No