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.: PACTR201912689388965 Date of Approval: 09/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Pre-emtive Pregabalin on Postoperative Pain, Deliberate Hypotension and Analgesic requirement for Patients Undergoing Dacryocystorhinostomy Surgery under Local Anesthesia.
Official scientific title Effect of Pre-emtive Pregabalin on Postoperative Pain, Deliberate Hypotension and Analgesic requirement for Patients Undergoing Dacryocystorhinostomy Surgery under Local Anesthesia.
Brief summary describing the background and objectives of the trial Background: Preoperative use of oral pregabalin was the cornerstone option for treatment of acute postoperative pain, a promising way on induced hypotension and reduction of postoperative analgesic requirement during Dacryocystorhinostomy operation. Aim of the work: Study was designed to estimate the effect of oral pregabalin on deliberate hypotension. Postoperative pain and total postoperative analgesic requirement during Dacryocystorhinostomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 01/08/2019
Actual Last follow-up date 01/08/2019
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group I Pregabalin Oral Capsule patients received pregabalin oral capsule 300 mg throughout the procedure where patients received pregabalin oral capsule 300 mg (Amoun pharmaceutical company, Egypt) two hours early morning the day of DCR operation with few sips of water. 40
Control Group Group II Placebo orla capsule where patients received placebo oral capsule throughout the preocedure where patients received placebo oral capsule two hours early morning the day of DCR surgery with few sips of water. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients included in our research were that enrolled for DCR operation with limited age between 25-60 years old and had American Society of Anesthesiologist physical status of I and II. While those with pregabalin hypersensitivity or its analogue, ASA III or IV or V, hepatic, renal insufficiency, respiratory disorders or chest problems, hypertensive patients, cardiac disorders, history of taking antihypertensive or β blockers or any cardiac medication, coagulation disorders, previous seizure, history of taking pregabalin previously, drug abuse, cognitive disorders and patients refused to share in study protocol; all were excluded from our research Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 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 10/04/2019 Faculty of medicine Aswan university
Ethics Committee Address
Street address City Postal code Country
El seel street Aswan 331111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain was assessed using 0-10 visual analogue score (VAS) where 0 represents no pain and 10 worst pain imaginable. Pain scores were recorded at 1, 2, 4, 8, 12, and 24h postoperative. Pain scores were recorded at 1, 2, 4, 8, 12, and 24h postoperative.
Secondary Outcome - The total dose of nitroglycerin (mg) used for each patients. - The quality of surgical field was also recorded using Fromm and Boezaart scale [12], where 0 grade represent no bleeding, 1 grade represent slight bleeding & no need for blood suction, 2 grade represent slight bleeding & sometimes blood has to be suctioned, 3 grade represent slight bleeding & blood has to be often suctioned (operative field was clear for few seconds after suction), 4 grade represent average bleeding & blood has to be frequent suctioned (operative field was clearly visible immediately after suction), 5 grade represent massive bleeding& regular blood suction required ( continuous non stopped bleeding that may be faster than suction and required another suction and multiple gauze ; hence surgical field became more obscured and non-visible that made the operation was so hard and may be difficult). - Time to first postoperative rescue analgesic request. - Total analgesic consumption in the first 24 h postoperatively was recorded. - Incidence of complications including postoperative nausea and vomiting (PONV), dizziness, somnolence, visual disturbance, headache, urine retention, hypotension, bradycardia, confusion, and sedation (assessed on a four-point scale where 0 = alert, 1 = quietly awake, 2 = asleep but easily aroused, and 3 = deep sleep) were recorded during first 24 hours postoperatively. during and after surgery end
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Aswan university el seel street Aswan 331111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sherif kamal hafez arafa Egypt- Tanta - 12 tout angh amoun street Tanta 331111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal arafa 12 tout angh amoun street tanta 331111 Egypt Funding Agency
Secondary Sponsor Amir abuozikary el sayed el gamal street Banha 331111 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa 12 tout angh amoun street Aswan 331111 Egypt
Amir abou zikary el sayed el gamal street Banha 331111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifarafa1020@gmail.com 01227744329 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 331111 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 01227744329 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 331111 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Sherif Arafa sherifarafa1020@gmail.com 01227744329 12 tout angh amoun street
City Postal code Country Position/Affiliation
Tanta 331111 Egypt lecturer of anesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1-Postoperative pain will be assessed using 0-10 visual analogue score (VAS) where 0 represents no pain and 10 worst pain imaginable (intolerable). Pain scores will be recorded at 1, 2, 4, 8, 12, and 24h postoperative. 2-The total dose of nitroglycerin (mg) that will be used for each patients will be recorded. The quality of surgical field will also be recorded using Fromm and Boezaart scale [12], where 0 grade represent no bleeding, 1 grade represent slight bleeding & no need for blood suction, 2 grade represent slight bleeding & sometimes blood has to be suctioned, 3 grade represent slight bleeding & blood has to be often suctioned (operative field is clear for few seconds after suction), 4 grade represent average bleeding & blood has to be frequent suctioned (operative field is clearly visible immediately after suction), 5 grade represent massive bleeding & regular blood suction will be required ( continuous non stopped bleeding that may be faster than suction and require another suction and multiple gauze; hence surgical field will become more obscured and non-visible that will make the operation so hard and may be difficult). Time to first postoperative rescue analgesic request, as well as total analgesic consumption in the first 24 h postoperatively will be recorded. Incidence of complications including postoperative nausea and vomiting (PONV), dizziness, somnolence, visual disturbance, headache, urine retention, hypotension, bradycardia, confusion, and sedation (will be assessed on a four-point scale where 0 = alert, 1 = quietly awake, 2 = asleep but easily aroused, and 3 = deep sleep) will be recorded during first 24 hours postoperatively. Study Protocol 2 years To those who request the data via e- mail of the principal investigator according to the cause of request
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