To compare the pain relief from combined intrathecal bupivacaine-morphine with bupivacaine alone in lower limb surgery
| ISRCTN | ISRCTN31685121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31685121 |
- Submission date
- 25/04/2022
- Registration date
- 12/05/2022
- Last edited
- 05/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Inadequate pain medication during and after surgery may lead to long term pain after surgery.
This study was designed to ascertain the effect of morphine addition to bupivacaine in the management of postoperative pain in patients undergoing lower limb surgeries at the Tamale Teaching Hospital, Ghana.
Who can participate?
Patients aged 16 – 60 years, undergoing lower limb surgery.
What does the study involve?
Participants will be randomly allocated to receive bupivicane alone or bupivicane plus morphine during surgery. Follow up lasts 72 hours.
What are the possible benefits and risks of participating?
Benefits: There were no immediate benefits for participation in the study. No gifts or money were given in exchange for the information obtained. However, data generated from this study will help policy makers in the Ministry of Health to improve the management of postoperative pain after Orthopaedic and Trauma surgeries.
Risks: Participants were informed that they may experience slight pain during the sample collection process. Should they suffer any injury during the collection process, members of the research team will take full responsibility and cover all expenses pertaining to treatment.
Where is the study run from?
Tamale Teaching Hospital, Ghana.
When is the study starting and how long is it expected to run for?
April 2021 to November 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Sylvanus Kampo, sylvanuskampo@yahoo.com
Fidelis Bayor, bayorfidelis@gmail.com
Contact information
Scientific
University of Ghana Medical School
Accra
24
Ghana
 ORCID ID |
0000-0002-2703-8856 |
|---|---|
| Phone | +233 249229949 |
| bayorfidelis@gmail.com |
Principal Investigator
CK Tedam University of Technology and Applied Sciences
Navrongo
19
Ghana
| Phone | +233 559355229 |
|---|---|
| sylvanuskampo@yahoo.com |
Study information
| Study design | Randomised comparative controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Analgesic efficiency of intrathecal bupivacaine with morphine and bupivacaine alone in lower limb orthopaedic surgery. A comparative study |
| Study acronym | IBM |
| Study objectives | Bupivacaine with morphine induces better postoperative pain relief and improve patient outcomes in lower limb orthopaedic surgery |
| Ethics approval(s) | Approved 30/09/2021, Ethical review board of the Kwame Nkrumah University of Science and Technology (University Post Office, Kumasi, Ghana; +233(0)205453785; chrpe@knust.edu.gh), ref: CHRPE/AP/416/21 |
| Health condition(s) or problem(s) studied | Postoperative pain management in trauma patients |
| Intervention | After meeting the inclusion criteria, eligible patients received 15 mg preservative free hyperbaric bupivacaine and 0.2 mg morphine or 15 mg bupivacaine alone. Patients were followed up 72 hrs for postoperative complications and patient outcome. Each recruited patient was randomly assigned to one of two groups using a computer-generated random number table. Group A (n=30) represented those who received bupivacaine alone and Group B (n=30) represented those who received bupivacaine with morphine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | bupivacaine, morphine |
| Primary outcome measure | 1. Vital signs (pulse rate, blood pressure, oxygen saturation, and respiratory rate) of the patient were monitored and recorded for every 5 minutes for the first 30 minutes and then for every 15 minutes during surgery 2. Pain severity was measured every 4 hours for 72 hours immediately after the surgery on a 100-mm VAS, 0 mm = no pain, and 100 mm = intolerable pain. |
| Secondary outcome measures | 1. The episodes of postoperative nausea and vomiting (PONV) were identified by direct scheduled assessments or by a spontaneous complaint by the patients after the surgery. The incidence of PONV was recorded hourly for the first 4 hours and then 4 hourly for the next 24 hours using a 3 point ordinal scale (0 = none, 1 = nausea, 2 = vomiting). The incidence of PONV was calculated and categorized as early (0 – 4 hours) or delayed (5 – 24hours). 2. The incidence of pruritus was recorded every 4 hours for 48 hours after surgery on a four-point categorical scale as; 0 = no pruritus, 1 = mild, 2 = moderate, 3 = severe pruritus. 3. Overall perioperative satisfaction was evaluated on the day of discharged during an interview as; 4 = excellent, 3 = good, 2 = satisfactory, 1 = poor. |
| Overall study start date | 01/04/2021 |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patients undergoing elective lower limb orthopaedic surgery 2. ASA status class I and II 3. Patients between 16 - 60 years of age 4. Patients who were on admission for 72 hours or more postoperatively |
| Key exclusion criteria | 1. Pregnant or breastfeeding mothers 2. Patients with polytrauma 3. Glasgow coma scale <15 4. Opioids abusers 5. Expected post-surgical stay <24 hours 6. ASA physical status class III and IV 7. Patients allergic to bupivacaine and/morphine 8. Contraindication to spinal anaesthesia |
| Date of first enrolment | 10/09/2021 |
| Date of final enrolment | 29/11/2021 |
Locations
Countries of recruitment
- Ghana
Study participating centre
Tamale
-
Ghana
Sponsor information
University/education
Korle Bu Teaching Hospital
University of Ghana Medical School
Accra
24
Ghana
| Phone | +233 249229949 |
|---|---|
| abuunaaim@yahoo.co.uk |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Study results will be presented at anaesthesia conferences in Ghana and planned publication will be made in a high-impact peer-reviewed journal |
| IPD sharing plan | Availability of data and materials: The datasets generated and/or analysed during the current study are not publicly available due to patient confidentiality but are available from the corresponding author on reasonable request. sylvanuskampo@yahoo.com |
Editorial Notes
05/05/2022: Trial's existence confirmed by Kwame Nkrumah University of Science and Technology.
