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.: PACTR201707002314115 Date of Approval: 23/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title pain relief after laparoscopic ovarian cystectomy
Official scientific title Efficacy of intraperitoneal different combinations of bupivacaine, hydrocortisone or magnesium sulfate for postoperative pain relief in patients undergoing day case laparoscopic ovarian cystectomy.
Brief summary describing the background and objectives of the trial Multimodal analgesia is necessary for management of pain after laparoscopic surgeries. Patients undergoing laparoscopic procedures experience postoperative pain especially in the abdomen, back, and shoulder region which require proper attention. Pain intensity usually peaks during the first postoperative hours. There are three components of pain after laparoscopic surgeries: 1.Visceral pain results from the stretching of the intraabdominal cavity and peritoneal inflammation. 2.Shoulder pain results from phrenic nerve irritation caused by residual carbon dioxide in the peritoneal cavity. 3.Parietal pain due to surgical incision which is much less in intensity by virtue of its small size. This study will assess the efficacy of intraperitoneal bupivacaine, hydrocortisone and magnesium sulfate in different combinations for postoperative pain relief in patients undergoing day case laparoscopic unilateral ovarian cystectomy. At the end of surgery with adequate hemostasis and after suctioning the peritoneal cavity of lavage solutions and blood, the study drugs combination will be instilled by the surgeon guided by the surgical camera. The 50 ml combination will be divided into 2 equal volumes (25 ml each). One of these volumes will be instilled subdiaphragmatically above the right hepatic lobe in reverse trendlenburg position. The other volume will be instilled over and around the surgical site (ovarian tissue) after returning the patient into the flat supine position. The surgeon will be asked to ensure complete deflation of the peritoneal cavity as much as possible
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied pain relief after laparoscopic ovarian cystectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2017
Actual trial start date 15/08/2017
Anticipated date of last follow up 15/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BM 20 ml bupivacaine 0.5% + 25 ml magnesium sulfate 10% + 5 ml saline 0.9%. once The 50 ml combination will be divided into 2 equal volumes (25 ml each). One of these volumes will be instilled subdiaphragmatically above the right hepatic lobe in reverse trendlenburg position. The other volume will be instilled over and around the surgical site (ovarian tissue) after returning the patient into the flat supine position. 30
Experimental Group BH 20 ml bupivacaine 0.5% + 100 mg hydrocortisone sodium succinate in 30 ml saline 0.9%. once The 50 ml combination will be divided into 2 equal volumes (25 ml each). One of these volumes will be instilled subdiaphragmatically above the right hepatic lobe in reverse trendlenburg position. The other volume will be instilled over and around the surgical site (ovarian tissue) after returning the patient into the flat supine position. 30
Experimental Group MH 25 ml magnesium sulfate 10% + 100 mg hydrocortisone sodium succinate in 25 ml saline 0.9%. once The 50 ml combination will be divided into 2 equal volumes (25 ml each). One of these volumes will be instilled subdiaphragmatically above the right hepatic lobe in reverse trendlenburg position. The other volume will be instilled over and around the surgical site (ovarian tissue) after returning the patient into the flat supine position. 30
Control Group C 50 ml normal saline 0.9% once The 50 ml combination will be divided into 2 equal volumes (25 ml each). One of these volumes will be instilled subdiaphragmatically above the right hepatic lobe in reverse trendlenburg position. The other volume will be instilled over and around the surgical site (ovarian tissue) after returning the patient into the flat supine position. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female ASA I-II scheduled for elective laparoscopic unilateral ovarian cystectomy under general anesthesia. History of cardiac, pulmonary or renal diseases. Patients with drug allergy to any of the study medications. Patients with known hypermagnesemia. Patients with history of chronic use of analgesics. Patients less than 50 kg body weight so that toxic doses of the studied drugs is not reached. Patients inability to understand the visual analogue scale. 18 Year(s) 35 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 21/05/2017 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Severity of postoperative pain (both abdominal & shoulder pain) both at rest (static) and during cough (dynamic) by visual analogue scale. 5 minutes after arrival of patient to the PACU every 2 hours (for 10 times)
Secondary Outcome Time till the first call for analgesia. the time from the completion of the surgery to the time when the first dose of analgesia is given at patient's request or when VAS is more than 4.
Secondary Outcome heart rate and mean arterial pressure immediately after instillation of the study drugs. every 5 minutes for the 1st hour then every 30 minutes for the next 6 hours then every 2 hours till the end of the study.
Primary Outcome Magnitude and time of the highest VAS score Single reading during the 24 hours
Primary Outcome Rescue analgesiac frequency and total consumption Overall frequency and total consumption
Secondary Outcome Incidence and severity of side effects( postoperative nausea and vomiting, shivering, sedation,and/or respiratory depression) During the whole postoperative duration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled gaballah 25 Yasin Abd-Elghafar street Shibin Elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 32511 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Public Enquiries khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 32511 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Scientific Enquiries khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 32511 Egypt lecturer in anaesthesia and intensive care medicine
REPORTING
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