NCT02708459

Brief Summary

Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

February 9, 2016

Last Update Submit

August 29, 2016

Conditions

Living Donor Hepatectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative morphine (mg) consumption in 1st 48 hours

    48 hours postoperative

Study Arms (3)

Control

ACTIVE COMPARATOR

Control group where postoperative analgesia will be maintained by Morphine intravenous boluses (2 mg) if Visual analogue scale (VAS) scale more than 4.

Drug: Intravenous morphine

Bupevecaine group

ACTIVE COMPARATOR

Postoperative analgesia will be maintained by 20 ml Bupevecaine (0.25%) boluses in surgically inserted TAP catheter each 8 hours for 48 hours with rescue analgesia intravenous morphine (2mg) if VAS more than 4

Device: surgically inserted Transversus abdominus plane catheterDrug: Intravenous morphineDrug: Bupevecaine

Dex group

ACTIVE COMPARATOR

catheter will surgically inserted in Transversus abdominus plane (TAP) plane before wound closure Postoperative analgesia will be maintained by Dexmedetomedine 0.4 mg/kg plus Bupevecaine 0.25 20 ml boluses each 8 hours for 48 hours in surgically inserted TAP catheter with rescue analgesia intravenous morphine (2mg) if VAS more 4

Device: surgically inserted Transversus abdominus plane catheterDrug: Intravenous morphineDrug: BupevecaineDrug: Dexmedetomedine

Interventions

surgically inserted Transversus abdominus plane catheterDEVICE

at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle

Bupevecaine groupDex group
Intravenous morphineDRUG

Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3

Bupevecaine groupControlDex group
BupevecaineDRUG
Bupevecaine groupDex group
DexmedetomedineDRUG
Dex group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all living hepatectomy donors in Mansoura liver transplantation program

You may not qualify if:

  • refusal known sensetivity to used drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura university

Al Mansurah, Dakahlia Governorate, 62215, Egypt

Location

Mansoura university

Al Mansurah, Dkahleya, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

EG(2)