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.: PACTR202103703462058 Date of Approval: 29/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Postoperative pain management in emergency abdominal surgery: bimodal versus unimodal analgesia
Official scientific title Postoperative pain management in emergency abdominal surgery: bimodal versus unimodal analgesia
Brief summary describing the background and objectives of the trial Emergency abdominal surgery is a common surgical procedure undertaken by surgeons to avert morbidity and mortality associated with acute abdomen. The pain after surgery can be distressful to patients if not optimally managed. Postoperative pain management in developing countries like Ghana is considered to be suboptimal. Strict protocols or clinical guidelines in managing pain after surgery are not available for health institutions in Ghana. In recent times, intravenous (i.v.) paracetamol has found its way into the management of postoperative pain in some hospitals in Ghana. Whilst this new trend seems to be growing rapidly especially in the teaching hospitals, a greater number of doctors still prescribe opioids such as morphine in the management of postoperative pain. In Ghana, there is a paucity of data comparing the efficacy of i.v. paracetamol and parenteral opioid as unimodal analgesia or a combination of both in postoperative pain management. Main Objective: To compare the efficacy of unimodal i.v. paracetamol and intramuscular (i.m). morphine with bimodal administration of the two drugs in managing postoperative pain after emergency abdominal surgery. Specific Objectives: i. To assess the response of patients to i.v. paracetamol in pain management after emergency abdominal surgery. ii. To assess the response of patients to i.m. morphine in pain management after emergency abdominal surgery. iii. To assess the response of patients to a combination of i.v. paracetamol and i.m. morphine in managing pain after emergency abdominal surgery. iv. To determine the association between the administered analgesic and length of hospital stay. v. To determine the association between administered analgesic and postoperative complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) STAR
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/04/2021
Actual trial start date
Anticipated date of last follow up 15/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 108
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intramuscular Morphine 10mg 8 hourly (18-60years old) 5mg 8 hourly (above 60 years old) 48 hours Participants in this group will receive only intramuscular morphine for post abdominal surgery pain management. There will be a pain assessment score using the Numerical Rating Scale or Colour-Circle Pain Scale (where the participant cannot appreciate the numerical scale). The pain assessment will be done in 1 hour, 3 hours, 6 hours, 12hours, and 24 hours after administration of the first dose. Participants with a score of 5 or more on the NRS or beyond yellow on the CCPS will receive rescue analgesia. 54
Control Group Morphine and Paracetmol 1g Paracetamol 8 hourly plus 10mg Morphine 8 hourly (18-60 years old) 1g Paracetamol 8 hourly plus 5 mg Morphine 8 hourly (above 60 years old) 48 hours Participants in this group will receive both intramuscular morphine and intravenous paracetamol for post abdominal surgery pain management. There will be a pain assessment score using the Numerical Rating Scale or Colour-Circle Pain Scale (where the participant cannot appreciate the numerical scale). The pain assessment will be done in 1 hour, 3 hours, 6 hours, 12hours, and 24 hours after administration of the first dose. Participants with a score of 5 or more on the NRS or beyond yellow on the CCPS will receive rescue analgesia. 54 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients between 18 and 80 years of age. Patients undergoing emergency abdominal surgery Anticipated abdominal incision of at least 5cm long Patients who consent to take part in the study Patients who are allergic to paracetamol or morphine Patients with impaired hepatic function or clinical features of liver disease Patients with renal impairment and CrCl < 60ml/min Patients with chronic opioid dependence Patients who are critically ill and may need ICU care Patients with a neuropsychiatric condition that may impair pain assessment Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
Patients between 18 and 80 years of age. Patients undergoing emergency abdominal surgery Anticipated abdominal incision of at least 5cm long Patients who consent to take part in the study Patients who are allergic to paracetamol or morphine Patients with impaired hepatic function or clinical features of liver disease Patients with renal impairment and CrCl < 60ml/min Patients with chronic opioid dependence Patients who are critically ill and may need ICU care Patients with a neuropsychiatric condition that may impair pain assessment Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 07/05/2021 Komfo Anokye Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Komfo Anokye Teaching Hospital, P.O.Box 1934 Kumasi AK0349094 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The efficacy of unimodal intravenous (i.v.) paracetamol and intramuscular (i.m.) morphine compared with bimodal administration of the two drugs in managing postoperative pain after emergency abdominal surgery. Time of administration of first dose of postoperative analgesia to 48 hours post first dose.
Secondary Outcome The response of patients to i.v. paracetamol in pain management after emergency abdominal surgery Time of administration of first dose of paracetamol to 48 hours post first dose.
Secondary Outcome The response of patients to i.m. morphine in pain management after emergency abdominal surgery Time of administration of first dose of morphine to 48 hours post first dose.
Secondary Outcome The response of patients to a combination of i.v. paracetamol and i.m. morphine in managing pain after emergency abdominal surgery. Time of administration of first dose of paracetamol plus morphine to 48 hours post first dose.
Secondary Outcome The association between the administered analgesic and length of hospital stay. Day of discharge
Secondary Outcome The association between administered analgesic and postoperative complications. Day of discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital Okomfo Anokye Road, P.O. Box 1934 Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Frank Enoch Gyamfi Komfo Anokye Teaching Hospital, P.O.Box 1934 Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Frank Enoch Gyamfi Komfo Anokye Teaching Hospital, P.O.Box 1934 Kumasi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frank Enoch Gyamfi v1gyamfi@ed.ac.uk +233208725806 Komfo Anokye Teaching Hospital
City Postal code Country Position/Affiliation
Kumasi Ghana Komfo Anokye Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Francis Aitpillah fraitp@yahoo.com +233244847433 Komfo Anokye Teaching Hospital, P.O.Box 1934
City Postal code Country Position/Affiliation
Kumasi Ghana Komfo Anokye Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Stephen Tabiri stabiri@uds.edu.gh +233201691005 University for Development Studies, P.O.Box TL 1350
City Postal code Country Position/Affiliation
Tamale Ghana University for Development Studies
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be available after deidentification. Informed Consent Form,Study Protocol Documents and data will be available 6 months after publication to 5 years Researchers whose proposal may seek to answer questions generated from this research and who will not use the data collected for commercial purpose.
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