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.: PACTR201803003108330 Date of Approval: 19/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postoperative Analgesic Efficacy of Transversus Abdominis Plane in Laparoscopic Abdominal Surgeries
Official scientific title Postoperative Analgesic Efficacy of Transversus Abdominis Plane (Ultrasound Guided) in Laparoscopic Abdominal Surgeries Using Levobupivacaine with Dexmedetomidine Versus Placebo: Prospective Randomized Double Blinded Controlled Clinical Trial
Brief summary describing the background and objectives of the trial The anterior abdominal wall is innervated by nerve afferents that course through the transversus abdominis neuro-vascular fascial plane. Transversus abdominis plane (TAP) block is popular for pain relief after abdominal surgery. TAP block has been used to optimize postoperative pain outcomes.Success of block is depend on identify the neuro-fascial plane between the internal oblique and the transversus abdominis muscles. Ultrasound-based studies have shown poor accuracy of blind abdominal wall injections Various adjuvants to increase the duration of block are used in the daily clinical practice. Clonidine, an ¿-2 adrenoceptor agonist, has been shown to prolong the duration of peripheral nerve blocks. Dexmedetomidine is a selective ¿-2 adrenoceptor agonist with an eight-fold affinity to the ¿-2 adrenoceptor compared with clonidine and was recently approved by the European Medication Agency for continuous i.v. sedation in critically ill patients. Animal studies showed that perineural dexmedetomidine added to local anesthetic prolongs the duration of sensory and motor block dexmedetomidine did not show toxicity and was potentially neuroprotective when combined with lidocaine and bupivacaine The aim of this study is to assess the effects of adding dexmedetomidine (either 0.5 or 1 mcg/Kg) as an adjuvant to levobupivacaine versus placebo (saline) on analgesic duration and postoperative analgesic requirement after laparoscopic abdominal surgeries
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
Disease(s) or condition(s) being studied Laparoscopic Abdominal Surgeries,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/02/2018
Actual trial start date
Anticipated date of last follow up 02/07/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Research Ethics Comittee Approval Code: 31891/11/17
Research Ethics Comittee Approval Code: 31891/11/17
Research Ethics Comittee, Faculty of Medicine, Tanta University Approval Code: 31891/11/17
Research Ethics Comittee Approval Code: 31891/11/17
Research Ethics Comittee, Faculty of Medicine, Tanta University Approval Code: 31891/11/17
Research Ethics Comittee, Faculty of Medicine, Tanta University Approval Code: 31891/11/17
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
Control Group Group I (levobup.) 0.2% After induction of general anesthesia patients will receive levobupivacaine 0.2% (60 ml) + 2ml placebo (saline)The amount of local anesthesia that will be injected (31ml) in each side. 20 Active-Treatment of Control Group
Experimental Group Group II (levobup. + Dex A) 0.5 mcg/kg After induction of general anesthesia patients will receive levobupivacaine 0.2% (60 ml) + 2ml dexmedetomidine (0.5 mcg/kg).The amount of local anesthesia that will be injected (31ml) in each side. 20
Experimental Group Group III (levobup. + Dex B) 1 mcg/Kg After induction of general anesthesia patients will receive levobupivacaine 0.2% (60 ml) + 2ml dexmedetomidine (1 mcg/Kg).The amount of local anesthesia that will be injected (31ml) in each side. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I ¿ III of both sex, between 18 and 60 years undergoing laparoscopic abdominal surgeries Open surgeries. - If the surgery proceeded to laparotomy. - BMI ¿ 35 Kg/m. - Known allergy or hypersensitivity against levobupivacaine, other amino-amide local anesthetics, or dexmedetomidine. - Coagulopathy; septicemia. - Abnormalities in ECG that are considered clinically relevant like AV block or bradycardia. 18 Year(s) 60 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 29/11/2017 Tanta University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El-Geish st Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the duration of analgesia (time required to receive 1st dose of morphine) Rescue analgesia 3 mg IV morphine was administered if VAS was > 4
Secondary Outcome the VAS score, and 24 hours morphine consumption visual analogue scale (VAS) for static and dynamic pain at 30 min, 1, 2, 4, 6, 8, 12, and 24 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals, Faculty of Medicine El-Geish st Tanta/ Gharbia 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Micheal Ramsy Elmansoury El-Geish st Tanta 31257 Egypt
Rehab Said El-Kalla El-Geish st Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Michael Rasmy Elmansoury El-Geish st Tanta 31257 Egypt Hospital
Primary Sponsor Rehab Said ElKalla El-Geish st Tanta/ Gharbia 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Michael Rasmy Elmansoury El-Geish st Tanta 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta / Gharbia 31257 Egypt Lecturer of anesthesiology and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Public Enquiries Michael Elmansoury mick_bengawy@hotmail.com +971561369900 El-Geish st
City Postal code Country Position/Affiliation
Abu Dhabi 31257 United Arab Emirates MD, Sheikh Khalifa Medical City
Role Name Email Phone Street address
Scientific Enquiries Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta / Gharbia 31257 Egypt Lecturer of anesthesiology and surgical ICU Faculty of medicine-Tanta University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information