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.: PACTR202310525672884 Date of Approval: 13/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analgesic effectiveness of wound infiltration with bupivacaine and a mixture of bupivacaine and tramadol for postoperative pain management among participants undergoing elective cesarean section under spinal anesthesia at dilla university general hospital, 2023: a double-blind randomized controlled trial
Official scientific title Analgesic effectiveness of wound infiltration with bupivacaine and a mixture of bupivacaine and tramadol for postoperative pain management among participants undergoing elective cesarean section under spinal anesthesia at Dilla university general hospital, 2023: a double-blind randomized controlled trial
Brief summary describing the background and objectives of the trial The prevalence of postoperative pain following cesarean section is still significant, ranging from 25.5 to 80%, despite improvements in our understanding of the pathophysiology of postoperative pain and the development of numerous postoperative analgesic medications and techniques. Wound infiltration is low-cost with a good safety margin and can be used as a component of a multimodal analgesic strategy to manage postoperative pain in resource-constrained areas. Although wound infiltration provides opioid-sparing analgesic effects, the relative effectiveness of this treatment is not well known.The most common pain management modalities are systemic and intrathecal administration of opioids, patient-controlled analgesia (PCA), non-steroidal anti-inflammatory drugs (NSAIDs), and regional nerve blocks. These modalities can be combined in multimodal analgesia, which results in synergistic analgesia with fewer side effects The objective of this study is to determine the analgesic effectiveness of wound infiltration with bupivacaine and a mixture of bupivacaine and tramadol for postoperative pain management among parturients undergoing cesarean section under spinal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 01/06/2023
Actual trial start date 03/06/2023
Anticipated date of last follow up 01/06/2023
Actual Last follow-up date 16/09/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
duirb/029/23-05
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bupivacaine alone 0.7 ml/kg of 0.25% bupivacaine 5 month 0.7 ml/kg of 0.25% bupivacaine is infiltrated at the wound site. 30 Active-Treatment of Control Group
Experimental Group Bupivacaine with tramadol 0.7 ml/kg of 0.25% bupivacaine with 2ml of tramadol 5 month 0.7 ml/kg of 0.25% bupivacaine with 2ml of tramadol is infiltrated at the wound site 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Pregnant mothers between 18 and 45  ASA class =II  Patients with known allergies to bupivacaine and tramadol  History of alcohol usage, opiate or other drug abuse  Pregnant mothers who diagnosed with Chronic pain  Pregnant mothers with systemic diseases like renal impairment, chronic liver disease, chronic obstructive pulmonary disease, and cardiac disease  Pregnant mothers with pre-eclampsia, eclampsia  Spinal anesthesia with adjuvants  Operation other than the lower uterine segment incision  Pregnant mothers taking opioids preoperatively Adult: 19 Year-44 Year 20 Year(s) 40 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 12/05/2023 The Institutional Review Board of Dilla University College of Health Science and Medicine
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 419 Ethiopia
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 12/05/2023 The Institutional Rview board of Dilla University College of Health Science and medicine
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative total Analgesia consumption in the first 24 hours Time to first analgesic request in minutes Postoperative Pain severity (NRS score (0–10 cm)) 2hr,6hr,12hr,18hr,24hr
Secondary Outcome Postoperative nausea and vomiting (3-point scale) 2hr,6hr,12hr,18hr,24hr
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Dilla Dilla 419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Dilla 419 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Dilla 419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mesay Milkias Wonte milikiasssi@gmail.com +251949180127 Dilla
City Postal code Country Position/Affiliation
Dilla 419 Ethiopia Dilla University
Role Name Email Phone Street address
Scientific Enquiries Semagn Mekonnen Abate semmek17@gmail.com +251913864605 Dilla
City Postal code Country Position/Affiliation
Dilla 419 Ethiopia Dilla University
Role Name Email Phone Street address
Public Enquiries Hailemariam Getachew Tesema hailemariamgetachew23@gmail.com +251912982067 Dilla
City Postal code Country Position/Affiliation
Dilla 419 Ethiopia Dilla University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Except for the principal investigator, no one will have access to your collected data, name, or anything taken from your chart. The data will be coded and locked, with no labeling specifying you or anyone else participating in the research. Informed Consent Form,Study Protocol 1 years open
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