TAP Donor: Transversus Abdominus Plane Block in Living Donor Hepatectomy

Sponsor

AlRefaey Kandeel (Other)

Overall Status

Completed

CT.gov ID

NCT02708459

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Living Donor Hepatectomy	Device: surgically inserted Transversus abdominus plane catheter Drug: Intravenous morphine Drug: Bupevecaine Drug: Dexmedetomedine	N/A

Detailed Description

Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery using three different drugs control group, Bupivecaine group, and Dexmedetomedine group

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control 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 Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3
Active Comparator: Bupevecaine group 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 catheter at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle Drug: Intravenous morphine Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3 Drug: Bupevecaine
Active Comparator: Dex group 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 catheter at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle Drug: Intravenous morphine Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3 Drug: Bupevecaine Drug: Dexmedetomedine

Arm

Intervention/Treatment

Active Comparator: Control

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

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

Active Comparator: Bupevecaine group

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 catheter

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

Drug: Intravenous morphine

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

Drug: Bupevecaine

Active Comparator: Dex group

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 catheter

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

Drug: Intravenous morphine

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

Drug: Bupevecaine

Drug: Dexmedetomedine

Outcome Measures

Primary Outcome Measures

postoperative morphine (mg) consumption in 1st 48 hours [48 hours postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all living hepatectomy donors in Mansoura liver transplantation program

Exclusion Criteria:

refusal known sensetivity to used drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university	Mansoura	Dakahleya	Egypt	62215
2	Mansoura university	Mansoura	Dkahleya	Egypt

Sponsors and Collaborators

AlRefaey Kandeel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AlRefaey Kandeel, Dr, Mansoura University

ClinicalTrials.gov Identifier:

NCT02708459

Other Study ID Numbers:

Abuelella TAP

First Posted:

Mar 15, 2016

Last Update Posted:

Aug 30, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Morphine

Study Results

No Results Posted as of Aug 30, 2016