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.: PACTR201803003216942 Date of Approval: 19/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title pain management for manual vacuum aspiration for incomplete miscarriage
Official scientific title Paracervical block versus pentazocine plus diclofenac in pain management for manual vacuum aspiration following first trimester miscarriage: A randomized controlled trial
Brief summary describing the background and objectives of the trial The choice of the method of pain control is guided by the doctor¿s preference, drug availability, financial considerations, individual preference, and history of drugs allergy and by institutional consensus. Para-cervical block is widely used to provide pain relief during manual vacuum aspiration and is recommended by international organisation and randomized controlled trial had demonstrated efficacy over placebo. Combined pentazocine and diclofenac have been shown to be more efficacious than single agent analgesics and is widely used in our environment. There had not been any study in Abakaliki, south -east Nigeria that evaluated the efficacy of methods used for pain relief during manual vacuum aspiration. Hence, this study is designed to evaluate the efficacy of paracervical block compared with combined pentazocine and diclofenac for pain relief during manual vacuum aspiration for first trimester miscarriage at the federal Teaching Hospital Abakaliki. AIM To compare the efficacy of paracervical block with combined pentazocine with diclofenac in pain management during manual vacuum aspiration for first trimester miscarriage SPECIFIC OBJECTIVES 1. To compare the mean pain score associated with each treatment modality 2. To compare the complications, if any associated with each treatment modality 3. To compare overall patient¿s satisfaction between the two modalities
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied miscarriage,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2018
Actual trial start date 19/03/2018
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date 31/08/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 randomisation using computer generated random numbers Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group paracervical group 18 mL of 1% lignocaine plus 2 mL 8.4% sodium bicarbinate prior to the MVA Two milliliters of this mixture is administered into the anterior lip of the cervix where the sponge forceps would be placed and following this the 2-, 10-, 4- and 8 O¿clock positions are infiltrated with the remaining drug with the aid of a size 20G spinal needle. 60 Active-Treatment of Control Group
Experimental Group pentazocin plus diclofenac group 60mg pentazocine plus 75mg diclofenac 30 mins before the procedure Sixty milligram of Pentazocine with 75mg diclofenac is administered prior to the procedure, diazepam may be required for anxiolytic 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with a first trimester incomplete miscarriage confirmed clinically, with a positive urine or serum pregnancy test or with an ultrasound, which have no contraindication to the use of the study drugs 1. Women who have known allergy to any of the study drugs 2. Patients who do not consent to the study. 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 12/06/2017 federal teaching hospital human research and ethics committee
Ethics Committee Address
Street address City Postal code Country
abakaliki ebonyi state 048221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Outcome Measures would be the mean pain score in booth group at the point of discharge from the facility (usually with 4 hours of the MVA).
Secondary Outcome 1. Need for additional analgesia at point of discharge from the hospital
Secondary Outcome 2. side effects of the drugs about 30 minutes after the MVA
Secondary Outcome 3. patient satisfaction at the point of discharge from the hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
federal taeching hospital abakaliki ebonyi state abakaliki abakaliki 048221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr obi vitus o 16 benigwenyi street abakaliki abakaliki 048221 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor federal teaching hospital abakaliki abakaliki abakaliki 048221 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr obi vitus o 16 benigwenyi street abakaliki abakaliki 048221 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator vitus obi obivitus04@gmail.com 08038884406 16 benigwenyi street abakaliki
City Postal code Country Position/Affiliation
abakaliki 048221 Nigeria consultant obstetrician gynaecologist
Role Name Email Phone Street address
Public Enquiries christian mgbafulu khris201@yahoo.com 08035394438 federal teaching hospital abakaliki
City Postal code Country Position/Affiliation
abakaliki 048221 Nigeria consultant obstetrician gynaecologist
Role Name Email Phone Street address
Scientific Enquiries adeniyi adebayo adebayoj2008@gmail.com 08068936112 federal teaching hospital abakaliki
City Postal code Country Position/Affiliation
abakaliki 048221 Nigeria chief resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information