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

NCT ID: NCT03393988

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2019-02-28

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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group F

Fentanyl infusion (0.5 µg/kg/hr)

Group Type ACTIVE_COMPARATOR

Fentanyl infusion

Intervention Type DRUG

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).

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).

Group Type ACTIVE_COMPARATOR

Fentanyl infusion

Intervention Type DRUG

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).

Ultrasound guided TAP block

Intervention Type PROCEDURE

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.

Dexmedetomidine

Intervention Type DRUG

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)

Interventions

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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).

Intervention Type DRUG

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.

Intervention Type PROCEDURE

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)

Intervention Type DRUG

Other Intervention Names

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Opioid Regional anesthesia alpha 2 sympathomimetic

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rasha Samir Abd-ElWahab Bondok

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospitals of Faculty of Medicine , Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R45/2017

Identifier Type: -

Identifier Source: org_study_id

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