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.: PACTR202003752686494 Date of Approval: 02/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sodium bicarbonate for peritoneal irrigation in diagnostic hysteroscopy-laparoscopy
Official scientific title Sodium bicarbonate based warm saline versus warm saline for peritoneal irrigation in diagnostic hysteroscopy-laparoscopy : A prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Diagnostic hysteroscopy-laparoscopy is a simple and common procedure in infertility. Carbon dioxide pneumoperitonium may produce postoperative pain due to acidic irritation. Sodium bicarbonate use may counter act this effect and reduce post operative pain
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VAS
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 18/02/2020
Actual trial start date
Anticipated date of last follow up 18/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status 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 Sodium bicarbonate with warm saline in peritoneal wash 50 ml sodium bicarbonate 8.4%+ 1000 ml warm saline 37c intraoperative peritoneal wash 25
Control Group warm saline 1000 ml warm saline 37c intra operative peritoneal wash 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
this study will be conducted on adult females ASA I or II aging 18-45 years undergoing diagnostic hysteroscopy-laparoscopy in mansoura university hospital • Patient refusal • Allergy to used drugs • Addiction • Altered liver or kidney function • Psychological problems. • Complicated procedure Adult: 19 Year-44 Year 18 Year(s) 45 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 15/02/2020 IRB Mansoura Faculty of Medicine Mansoura University
Ethics Committee Address
Street address City Postal code Country
elgomhoria street mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain assesment by VAS 0,1,2,4,6,12,24 Hour post operative
Secondary Outcome pethidine consumption 24 hour post operative
Secondary Outcome incidence of shoulder and subdiaphragmatic pain 24 hour postoperative
Secondary Outcome heart rate , mean arterial blood pressure ,spo2 0,1,2,4,6,12,24 hour post operative
Secondary Outcome nausea, vomiting 24 hour post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elgomhoria street el mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed abouelela khatab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university elgomhoria street elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed abouelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia and SICU faculty of medicine mansoura university egypt
Role Name Email Phone Street address
Public Enquiries mohamed abouelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries mohamed abouelelea aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of ananesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study design, methodolgy, results Clinical Study Report,Study Protocol 12 month after completion of study across IRB mansoura university
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