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.: PACTR202011631035873 Date of Approval: 02/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PRE-EMPTIVE USE OF ORAL TRAMADOL VERSUS PREGABALIN IN THE MANAGEMENT OF POSTOPERATIVE PAIN AFTER DIAGNOSTIC GYNECOLOGICAL LAPAROSCOPIC SURGERY
Official scientific title PRE-EMPTIVE USE OF ORAL TRAMADOL VERSUS PREGABALIN IN THE MANAGEMENT OF POSTOPERATIVE PAIN AFTER DIAGNOSTIC GYNECOLOGICAL LAPAROSCOPIC SURGERY
Brief summary describing the background and objectives of the trial Laparoscopic surgery, also called minimally invasive surgery, or keyhole surgery, (usually 0.5-1.5 cm) . So it is the gold standard in gynecologic surgery based on its advantages which include less patient discomfort, shortened hospital stay, quicker recovery. Post-surgical pain is a complex response to tissue trauma during surgery that stimulates hypersensitivity of the central nervous system. High-quality pain control after day-case surgery is still a major challenge. Although opioids continue to have an important role in postoperative pain management, they have side-effects. A multimodal approach has been suggested to improve postoperative analgesia and to reduce the opioid-related side-effects. Pre-emptive analgesia is the administration of an analgesic before a painful stimulus, such as tissue injury during surgery. The aim of the study is to evaluate and compare the effects of preoperative oral tramadol versus preoperative oral pregabalin for postoperative pain control in diagnostic laparoscopic gynecological surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postoperative pain control in diagnostic laparoscopic gynecological surgery.
Purpose of the trial Prevention
Anticipated trial start date 30/04/2019
Actual trial start date 30/04/2019
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date 31/08/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral tramadol 100 mg once 2hours before surgery 100 mg of oral tramadol 2 hours before the surgery. 20
Experimental Group Oral pregabalin 150 mg once 2hrs before surgery 150 mg of oral pregabalin 2 hours before the surgery 20
Control Group placebo placebo tablet 2hrs before surgery placebo 2 hours before the surgery 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I or II female patients scheduled for elective diagnostic gynecological laparoscopic surgery - Patient refusal - Patient inability to properly describe postoperative pain to the observer (dementia, delirium, psychiatric and neurological disorder) - Preoperative opioid or non-steroidal anti-inflammatory drug consumption or history of opioid addiction, - Allergy to pregabalin or tramadol - History of asthma or Seizures or Chronic pain syndrome. Adult: 19 Year-44 Year 20 Year(s) 40 Year(s) Female
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 21/03/2019 Ethics Committee Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale Direct after extubation, after 1,2,4,6,12,18,24 hours postoperative
Secondary Outcome Total postoperative analgesic consumption, Total dose during the first 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elshatby maternity university hospital Port saeed street, El-Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mariam mohammed mohammed hussein Elshatby maternity university hospital Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University 17 champlion street elmessalah Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Salwa shaaban abbas shaarawi Port saeed street, El-Shatby Alexandria 21526 Egypt
Hisham fouad anwar Port saeed street, El-Shatby Alexandria 21526 Egypt
Sally ahmed roshdy elmedany Port saeed street, El-Shatby Alexandria 21526 Egypt
Mariam mohammed mohammed hussein Port saeed street, El-Shatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salwa Shaarawi Salwashaarawy@yahoo.com 00201223425079 Port saeed street, El-Shatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Hisham Anwar hfanwer@yahoo.com 00201001449108 Port saeed street, El-Shatby
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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