- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02708459
Transversus Abdominus Plane Block in Living Donor Hepatectomy (TAP Donor)
August 29, 2016 updated by: AlRefaey Kandeel
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
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahleya
-
Mansoura, Dakahleya, Egypt, 62215
- Mansoura University
-
-
Dkahleya
-
Mansoura, Dkahleya, Egypt
- Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all living hepatectomy donors in Mansoura liver transplantation program
Exclusion Criteria:
- refusal known sensetivity to used drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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
|
Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3
at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle
|
|
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
|
Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3
at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative morphine (mg) consumption in 1st 48 hours
Time Frame: 48 hours postoperative
|
48 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
March 14, 2016
First Posted (Estimate)
March 15, 2016
Study Record Updates
Last Update Posted (Estimate)
August 30, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abuelella TAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Living Donor Hepatectomy
-
National Taiwan University HospitalCompleted
-
Mansoura UniversityCompleted
-
Mansoura UniversityCompleted
-
Second Affiliated Hospital, School of Medicine,...Mukogawa Women's UniversityRecruitingLiving Donor Liver Transplantation Recipients | Deceased Donor Liver Transplantation Recipients | Living Liver DonorChina
-
Marengo Asia HospitalsRecruiting
-
London Health Sciences Centre Research Institute...CompletedCardiovascular Disease | Mortality | Living Kidney Donors | Living Kidney Donor | Living Donor Nephrectomy | Living Kidney Donation | Major Adverse Cardiovascular Events (MACE)
-
Beth Israel Deaconess Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Columbia UniversityWithdrawnLiving Renal DonorUnited States
-
London Health Sciences Centre Research Institute...Canadian Institutes of Health Research (CIHR)Completed
Clinical Trials on Intravenous morphine
-
Javelin PharmaceuticalsCompletedPost-Operative Pain | Third Molar Extraction
-
University of MonastirCompletedPost Traumatic PainTunisia
-
University Tunis El ManarActive, not recruiting
-
Medical University of WarsawUnknownLiver Diseases | Liver Metastases | Liver CancerPoland
-
Charles University, Czech RepublicCompletedEpidural Analgesia | Morphine | Analgesia, Patient-Controlled | Anesthesia; Spinal | Surgery, Colorectal | Intravenous Drug Delivery SystemsCzechia
-
Javelin PharmaceuticalsCompleted
-
Assiut UniversityUnknownAbdominal ObesityEgypt
-
Peking University First HospitalCompletedEpidural Analgesia | Total Knee Arthroplasty | Adult Patients | Analgesic Adverse Reaction | Femoral Nerve BlockChina
-
Columbia UniversityCompletedPain | AbscessUnited States
-
South Egypt Cancer InstituteUnknownBreast Cancer FemaleEgypt