Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201703002081320 Date of Approval: 07/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transversus Abdominis Plane Block levobupivacaine plus ketamine in abdominoplasty
Official scientific title Transversus Abdominis Plane Block ¿TAP¿: A Comparative Study between levobupivacaine versus levobupivacaine plus ketamine in abdominoplasty
Brief summary describing the background and objectives of the trial Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance. Transversus abdominis plane (TAP) block was first described by Rafi in 2001, provides analgesia to the anterolateral abdominal wall by injecting local anesthesia into the plane between the internal oblique and transversus abdominis muscle and thus giving pain relief. TAP block has been found to be a safe and effective tool in a variety of general, gynecological, urological, plastic, and pediatric surgeries, and it is suggested as part of the multimodal anesthetic approach to enhance recovery after lower abdominal surgeries. Local diffusion into the TAP requires a large volume of anaes¬thetic to determine the effective spread on interested nerves: all authors suggested a median volume of 15-20 ml of anaesthetic for each puncture and this raises the issue of potentially toxic plasma concentrations of the local anaesthetic. The addition of ketamine to a local anesthetic or other analgesics in peripheral or neuraxial anesthesia and analgesia improves or prolongs pain relief. A decrease in drug-related side effects (sedation, pruritus, or adverse psychological reactions) has also been found, mainly because the required drug doses could be reduced. These effects may relate to blockade of central and peripheral NMDA receptors and/or an antinociceptive action complementary to that of the other drugs used. Central and peripheral sensitization may thus be prevented. Aim of the work The aim of this study to compare the effectiveness of adding ketamine to levobupivacaine in TAB in patient undergoing abdominoplasty.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,perio-perative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2016
Actual trial start date 01/08/2016
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
30915/05/16 Research ethics committiee faculty of medicine tanta university
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TAP block with levopupivacaine .5% 15 ml plus ketamine 0.5 mg/kg in total volume 20 once Intra-operative before surgical incision Bilateral ultrasound-guided TAP block will be introduce after induction of general anesthesia but before surgical incision Once the needle tip reaches the TAP, 1 to 2 mL of normal saline or local anesthetic can be injected to confirm needle placement. The injected solution will appear as a hypoechoic or dark area between the fascial layers 25
Control Group TAP block with levopupivacaine .5% 15 ml plus 5 ml normal saline in total volume 20 once Intra-operative before surgical incision Bilateral ultrasound-guided TAP block will be introduce after induction of general anesthesia but before surgical incision Once the needle tip reaches the TAP, 1 to 2 mL of normal saline or local anesthetic can be injected to confirm needle placement. The injected solution will appear as a hypoechoic or dark area between the fascial layers 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of American Society of Anesthesiologist (I, II), aged from 25 to 50 year of both sex undergoing abdominoplasty will be enrolled in the study Body mass index ¿¿BMI¿¿ > 35 kg/m2, allergies to local anesthetic, alcohol or drug abuse, coagulation disorders, mental or physical illness interfere with evaluation of VAS 25 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/05/2016 Research ethics committe faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
El Gaish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain at 2h, 4h, 6h, 8h, 12h, 16,20h and 24h after recovery
Secondary Outcome Overall patient satisfaction at 48hr
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals El-Gaish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University hospitals El-Gaish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University hospitals El-Gaish street Tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Radwa Fathy Mansour Elnady street Tanta 31516 Egypt
Mohammed Elbrol Abd Elgaleel st Tanta 31528 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Mansour rodywael@yahoo.com 00201005255397 Elnady Street
City Postal code Country Position/Affiliation
Tanta 31516 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Sameh Abd Elkhalik dr_sameh_100@yahoo.com 0201002977048 10th Mostafa Kamel street
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohammed Elbrol moh7000@yahoo.com 0201063345623 Abd Elgaleel st
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
REPORTING
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Result URL Hyperlinks Link To Protocol
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Changes to trial information