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.: PACTR202103915814652 Date of Approval: 04/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Patient Controlled Analgesia (PCA): Intravenous versus Epidural Morphine in Morbidly Obese Patients undergoing Laparoscopic Sleeve Gastrectomy
Official scientific title Patient Controlled Analgesia (PCA): Intravenous versus Epidural Morphine in Morbidly Obese Patients undergoing Laparoscopic Sleeve Gastrectomy: A Comparative Study
Brief summary describing the background and objectives of the trial Postoperative complications in patients with morbid obesity have been consistently linked to increasing body mass index (BMI), and the use of opioids has been found to have strong association in precipitating the same. Patients with morbid obesity show unique physiological alterations that modify both pharmacokinetics and pharmacodynamics of opioids eventually predisposing them to increased sensitivity towards unwanted sedative effect. Bearing these concerns in mind it is not uncommon to undertreat perioperative pain in patients with morbid obesity. Instead of relying primarily upon opioids, one must use combinations of analgesics that act by different mechanisms and add to analgesic efficacy rather than adverse effects. In this study we will compare the use of Patient Controlled Analgesia (PCA): Intravenous versus Epidural Morphine in Morbidly Obese Patients undergoing Laparoscopic Sleeve Gastrectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 13/03/2021
Actual trial start date 13/03/2021
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PCA with intravenous morphine group an initial loading dose of up to 2.5-5 mg intravenous morphine. Then, the PCA pump is programmed to deliver a 1mg intravenous morphine bolus per hour with a lockout interval of 8 min. 1mg intravenous morphine bolus per hour In the post-anesthesia care unit (PACU), the PCA group (n=30) began analgesia by an initial loading dose of up to 2.5-5 mg intravenous morphine. Then, the PCA pump (Graseby 3300; Graseby Medical, Vitry, France) is programmed to deliver a 1mg intravenous morphine bolus per hour with a lockout interval of 8 min. After 60 min if analgesia is inadequate VAS score > 3, the dose will be increased by 0.5 mg every hour to a maximum dose of 2 mg. If analgesia is still inadequate ketolace 30 mg will be administered IV every 12 hr. 30 Active-Treatment of Control Group
Experimental Group PCA group with epidural with bupivacaine and morphine 0.125% bupivacaine and 0.05mg\ml morphine mixture with a PCEA pump 2-ml bolus with a lockout interval of 30 min and a background infusion of 5 ml/h. In PCEA group (n=30), analgesia began postoperative by administration of a 0.125% bupivacaine and 0.05mg\ml morphine mixture with a PCEA pump (APM; Abbott Laboratories, Paris, France) which is programmed to deliver a 2-ml bolus with a lockout interval of 30 min and a background infusion of 5 ml/h. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
body mass index (BMI) ≥ 40 kg/m2, age from 19-45 years, American Society of Anesthesiologists status II or III presence of contraindications to epidural anesthesia (e.g., coagulopathy, localized skin infection), Patients with a history of chronic opioid use or chronic pain, history of psychiatric problems or who were currently on psychotropic medications, preexisting neurological deficit, allergy to local anesthetic or opioid, inability to use a PCA device or to comprehend pain scales. Adult: 19 Year-44 Year 19 Year(s) 45 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 28/02/2021 Department of Anesthesia and Intensive Care faculty of medicine Menoufia University.
Ethics Committee Address
Street address City Postal code Country
25 Yassin abdel-Ghaffar street Shebin Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total amount of morphine consumption during the 48-h postoperative period during the 48-h postoperative period
Secondary Outcome - Pain scores measured by VAS 4, 8, 12, 24, 36, and 48 h postoperatively
Secondary Outcome Sedation scale. 4, 8, 12, 24, 36, and 48 h postoperatively.
Secondary Outcome - Side effects included Nausea / or vomiting, pruritus and respiratory depression 4, 8, 12, 24, 36, and 48 h postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yassin abdel-Ghaffar street Shebin Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nadia M. Bahgat 25 Yassin abdel-Ghaffar street Shebin Elkom 32511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nadia Bahgat dr_nmbahgat@med.menofia.edu.eg +2001009558238 25 Yassin abdel-Ghaffar street
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Lecturer in Department of Anesthesia and Intensive Care Menofia University
Role Name Email Phone Street address
Public Enquiries Ayman Rayan ayman_rayan55@yahoo.com +966595830018 25 Yassin abdel-Ghaffar street
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Assistant professor Department of Anesthesia and Intensive Care Menofia University
Role Name Email Phone Street address
Scientific Enquiries Ayman Rayan ayman_rayan55@yahoo.com +966595830018 25 Yassin abdel-Ghaffar street
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Assistant professor Department of Anesthesia and Intensive Care Menofia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age, sex, body mass index, operation time, heart rate, arterial blood pressure, oxygen saturation, VAS pain score, Morphine and bupivacaine consumption, Modified Bromage score, Sedation level using a modified Observer’s Assessment of Alertness/Sedation (OAA/S) scale, satisfaction scores, Nausea and pruritus will recorded. Informed Consent Form,Study Protocol after 6 months data will be collected after farther 3 months tables and statistical analysis will be present. age, sex, body mass index, operation time, heart rate, arterial blood pressure, oxygen saturation, VAS pain score, Morphine and bupivacaine consumption, Modified Bromage score, Sedation level using a modified Observer’s Assessment of Alertness/Sedation (OAA/S) scale, satisfaction scores, Nausea and pruritus will recorded.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information