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.: PACTR201702002039148 Date of Approval: 13/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title dexmedetomidine levobupivavcaine
Official scientific title Intraperitoneal Levobupivacaine alone or with dexmedetomidine for postoperative analgesia after laparoscopic cholecystectomy.
Brief summary describing the background and objectives of the trial Laparoscopic cholecystectomy recently is the most commonly performed procedure for gall stones. Laparoscopic surgery has many advantages over open procedures such as lesser hemorrhage, better cosmosis, lesser postoperative pain, and shorter recovery time, leading to shorter hospital stay and less expenditure. Pain results from stretching of the intra¿abdominal cavity, [3] peritoneal inflammation, and diaphragmatic irritation caused by residual carbon¿dioxide in the peritoneal cavity. Many methods have been proposed to relieve post¿operative pain following laparoscopic cholecystectomy. Intraperitoneal instillation of local anesthetic agents alone or in combination with opioids, ¿¿2 agonists such as clonidine and dexmedetomidine have been found to reduce post¿operative pain following laparoscopic cholecystectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2017
Actual trial start date 01/03/2017
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 120
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
nil known R/16.03.87
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 Simple randomisation using a radomisation table created by a computer software program Masking/blinding 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 Simple randomisation using a radomisation table created by a computer software program Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group saline 40 ml hours saline 35 Placebo
Experimental Group levobupivacaine group 40 ml 24 h levobupivacaine 35
Experimental Group levobupivacaine dexmedetomidinegroup 40 ml 24 h levobupivacaine dexmedetomidine 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. Patients aged 20-50 years of either sex belonging to ASA physical status I or II planned for laparoscopic cholecystectomy Patient unwillingness, ASA physical status Class III or above and surgeon request for change of technique.need of surgical drain 20 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 05/04/2016 Mansoura Faculy of medicine
Ethics Committee Address
Street address City Postal code Country
Algomhuria st Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain the antinociceptive effects of dexmedetomidine when added to intraperitoneal levobupivacaine in patients undergoing laparoscopic cholecystectomy.
Secondary Outcome duration of postoperative analgesia 1st hour 2nd hour 4th hour 6th hour 12 hour 24 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Algomhuria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura aculty of medicine Al Gomhuria Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Maher Beder El baz Ahmed Maher st Mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Maher Beder El baz Ahmed Maher st Mansoura Egypt
Tamer el matwally torel Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed El baz mmaherelbaz@hotmail.com 00201003729881
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Public Enquiries mohamed el baz mmaherelbaz@hotmail.com 0020100729881 1 taksem khattab from ahmed maher st
City Postal code Country Position/Affiliation
Mansoura Egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed el baz mmaherelbaz@hotmail.com 0020100729881 1 takseem khattab from ahmed maher
City Postal code Country Position/Affiliation
Mansoura Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information