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.: PACTR202201644616894 Date of Approval: 14/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preoperative oral pregabalin 150 mg versus 300 mg in total hip arthroplasty: effects on duration of spinal anesthesia and postoperative pain
Official scientific title Preoperative oral pregabalin 150 mg versus 300 mg in total hip arthroplasty: effects on duration of spinal anesthesia and postoperative pain
Brief summary describing the background and objectives of the trial Background: Total hip arthroplasty is associated with acute postoperative pain.Patients are usually elderly and may have associated medical comorbidities. Methods: The patients will be randomized into three equal groups using a computer generated tables of random numbers.The first group will receive placebo capsule ( C Group ), the second group will receive pregabalin 150 mg capsule ( pregabalin 150 Group ), and the third group will receive pregabalin 300 mg capsule ( pregabalin 300 Group ).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 129
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pregabalin 150 mg Single dose Pregabalin 150 mg capsule will given orally one hour before giving spinal anesthesia 43
Experimental Group Pregabalin 300 mg Single dose Pregabalin capsule 300 mg will be given orally one hour before giving spinal anesthesia 43
Control Group Placebo Single dose Single dose Placebo capsule will be given orally one hour before giving spinal anesthesia 43 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A total of 129 patients scheduled to undergo total hip arthroplasty under spinal anesthesia, aged 40-60 years, and ASA I-II will be enrolled in this study. Exclusion criteria will include: (1) uncooperative patient, (2) allergy or contraindication to pregabalin, (3) preoperative use of antidepressants or anticonvulsants, (4)preoperative routine use of non-steroidal anti-inflammatory drugs (NSAIDs) or opioids, (5) drug or alcohol abuse, (6) history of diabetes mellitus, (7) impaired kidney function. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 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 15/12/2021 Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algomhoria St Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the duration of sensory and motor block Single measurement
Secondary Outcome The secondary outcome will be postoperative morphine consumption, pain score, and occurrence of any side effects. Pain score at 2, 6, and 24 hours postoperative.Morphine consumption over 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Algomhoria St Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Mahmoud Mahdy Mahmoud 42 Aleman St Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Algomhoria St Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mahmoud drmohamed.mahdy@yahoo.com 00201114781275 42 Aleman St
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer Anesthesia and Surgical ICU Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Mohamed Mahmoud drmohamed.mahdy@yahoo.com 00201114781275 42 Aleman St
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer Anesthesia and Surgical ICU Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mahmoud drmohamed.mahdy@yahoo.com 00201114781275 42 Aleman St
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer Anesthesia and Surgical ICU Faculty of Medicine Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share the study protocol and tables of results Informed Consent Form,Statistical Analysis Plan,Study Protocol Within six months after finishing the study With any individual or institutional request covered by an appropriate ethical committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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