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.: PACTR202107706925314 Date of Approval: 28/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pentazocine With Rectal Diclofenac Versus Pentazocine Alone for Pain Relief Following Caesarean Delivery: A Randomised Controlled Trial
Official scientific title Pentazocine With Rectal Diclofenac Versus Pentazocine Alone for Pain Relief Following Caesarean Delivery: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Over the years, the proportion of women having caesarean deliveries have been on the increase. Adequate post caesarean analgesia is indispensable in ensuring that the pain is reduced to the barest minimum. However, this is not always the case as most patients still complains of inadequate pain relief after surgery, hence the need for this study. Due to poor provision of adequate analgesia post caesarean delivery, there is the need to offer a modality of pain relief after surgery that is effective and safe. Provision of effective post-operative analgesia is critical because women who undergo caesarean delivery rank avoidance of pain during and after surgery as their highest priority. Also, poor management of pain after caesarean delivery may have long term effects and severe post-operative pain may be associated with persistent pain, delayed recovery and increased postpartum depression. The objectives of this trial are to determine and compare patient’s level of pain perception, level of patient’s satisfaction following pain relief and determine rate of need for breakthrough analgesia following administration of pentazocine and rectal diclofenac in one arm and pentazocine alone among patients undergoing caesarean delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Caesarean Delivery
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/07/2021
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Pentazocine only group IM, 60mg 6 hourly 48 hours 60mg of pentazocine was given within 1 hour after end of surgery and continue 6 hourly until 48 hours after caesarean section..the injections were administered to the nurses in the post natal ward 100 Active-Treatment of Control Group
Experimental Group Pentazocine and Rectal Diclofenac Group 30mg of pentazocine (IM) 6 hourly 100mg of Rectal Diclofenac 12 hourly 48 hours After the caesarean section, the above drugs are administered to the patients within an hour of end of surgery by the nurses in the post-natal ward 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting women with lower segment caesarean delivery under spinal anaesthesia Women with term gestations (37-42 weeks) Women with singleton pregnancy Women with known history of peptic ulcer disease Women with allergies to NSAIDs and pentazocine Sickle cell disease patients Asthmatic patients Patients who had still births Patients with opiod dependency Obese women Patients who had still births Patients with morbidities that may affect pain management Patients who may have complicated and prolonged surgeries (lasting over 90 minutes) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 24/07/2021 ESUT Teaching Hospital Parklane Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Parklane Enugu 400283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The level of pain perception measured using the VAS for pain. The VAS for pain Measured 12 hourly starting 1 hour after surgery
Secondary Outcome Level of satisfaction with pain relief, 48 hours after surgery
Secondary Outcome Need for breakthrough analgesia Measured as often as required within the first 48 hours of surgery
Secondary Outcome Maternal side effects Measured sporadically within the first 48 hours of surgery
Secondary Outcome Time of onset of bowel movement Measured within 48 hours of surgery
Secondary Outcome Time of onset of ambulation Measured within 48 hours of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ESUT Teaching Hospital Parklane Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ifeanyichukwu Ofor 20 Chief Jude Agu Crescent, New Town Layout, New Haven Extension Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ofor Ifeanyichukwu 20 Chief Jude Agu Crescent, New Town Layout, New Haven Extension Enugu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Enebe JT Department of Obstetrics and Gynaecology, ESUT Teaching Hospital Enugu Nigeria
Dr. Onyia CN Department of Obstetrics and Gynaecology ESUT Teaching Hospital Enugu Nigeria
Dr. Eleje GU Department of Obstetrics and Gynaecology, NAUTH Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeanyichukwu Ofor ofor.ifeanyi@gmail.com +2348037546411 20 Chief Jude Agu Crescent New Town Layout, New Haven Extension
City Postal code Country Position/Affiliation
Enugu Nigeria Specialist Registrar
Role Name Email Phone Street address
Public Enquiries Ifeanyichukwu Ofor ofor.ifeanyi@gmail.com +2348037547411 20 Chief Jude Agu Crescent New Town Layout, New Haven Extension
City Postal code Country Position/Affiliation
Enugu Nigeria Specialist Registrar
Role Name Email Phone Street address
Scientific Enquiries Uchenna George Eleje gu.eleje@unizik.edu.ng +2348068117444 No 49 Nnewi onitsha road Nnewi
City Postal code Country Position/Affiliation
Nnewi Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data and results of finding shall be shared at the end of the research Informed Consent Form,Study Protocol Within 6 months of completing the study Public
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