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.: PACTR202404574700044 Date of Approval: 18/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of paracervical block versus conscious sedation for pain relief during manual vacuum aspiration: A randomized controlled trial
Official scientific title Evaluation of paracervical block versus conscious sedation for pain relief during manual vacuum aspiration: A randomized controlled trial
Brief summary describing the background and objectives of the trial Manual vacuum aspiration is often performed in the first trimester for the management of miscarriages and causes significant pain to the patients. One of the most important aspects of surgical intervention in treating abortions is sufficient pain control during the process of evacuating the uterus. In addition to ensuring the woman remains as comfortable as possible during manual vacuum aspiration, a good pain relief option increases patients' safety, satisfaction as well as overall satisfaction. However, adequate pain control during this life-saving procedure remains a challenge to the Gynecologist. This study will compare the analgesic effectiveness and safety of paracervical block and conscious sedation in women undergoing manual vacuum aspiration for incomplete abortion. This will be a hospital-based open-label randomized controlled trial in which 66 eligible women will be randomized into two groups. Group A (paracervical group) will receive paracervical block using 1% lignocaine while group B (conscious sedation) will receive intravenous 30mg pentazocine and 10mg diazepam. Intraoperative and postoperative pain scores will be evaluated. Safety of both analgesic agents, overall physician and patient satisfaction will also be assessed
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/10/2023
Actual trial start date 01/11/2023
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Paracervical block 10mls of 1% lignocaine Stat dose A Cusco speculum is inserted into the vagina and the cervix is visualized. The 4, 8 and 12 o’clock positions of the cervix will be identified and two milliliters of 1% lidocaine will be injected at the 12 o’clock position. With the tenaculum at the injection site, slight traction will then be applied on the cervix to reveal the cervicovaginal junction. Using a 10ml syringe 4mls of 1% lignocaine will be injected at the 4 and 8 o’clock positions respectively at the cervicovaginal junction at a depth of 2cm using a 23-gauge injection needle, care being taken to aspirate before injection to avoid intravascular injection. A latency period of approximately 3 minutes will be given before uterine evacuation will commence to allow for onset of action of the anaethetic agent. 33
Control Group Conscious sedation Intravenous 30mg Pentazocine and 10mg Diazepam. Stat dose Pentazocine 30mg and diazepam 10mg will be administered through the intravenous access obtained on the dorsal aspect of the hand. A latency period of 3 minutes will be allowed for maximal analgesic function before the commencement of uterine evacuation (MVA). 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who give consent. Women at less than 13 weeks gestation with incomplete abortion. Women with psychiatric or neurological disorders. Women with an allergy to Lignocaine, Pentazocine and/or Diazepam. Women with septic abortion. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 20/06/2023 UPTH Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Port Harcourt Teaching Hospital Port Harcourt 500001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean pain scores of participants who will receive either form of analgesic agent. Need for additional analgesia intraoperatively. Ten minutes, thirty minutes, one hour
Secondary Outcome Incidence of side effects experienced with either analgesic agent. Participant satisfaction with assigned analgesic. One hour after completion of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Port Harcourt Teaching Hospital Choba Port Harcourt 500001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Emmeh Sweiyi Fiddo Alakahia Port Harcourt 500001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Emmeh Sweiyi Fiddo UPTH Port Harcourt 500001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Goddy Bassey Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital Port Harcourt 500001 Nigeria
Dr Terhemen Kasso Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital Port Harcourt 500001 Nigeria
Dr Ayanate Oruobo Nwogu Department of Anaesthesia, University of Port Harcourt Teaching Hospita Port Harcourt 500001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmeh Fiddo vivacious_emmeh@yahoo.com +2347032034078 Alakahia
City Postal code Country Position/Affiliation
Port Harcourt 500001 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Emmeh Fiddo vivacious_emmeh@yahoo.com +2347032034078 Alakahia
City Postal code Country Position/Affiliation
Port Harcourt 500001 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Emmeh Fiddo vivacious_emmeh@yahoo.com +2347032034078 Alakahia
City Postal code Country Position/Affiliation
Port Harcourt 500001 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants' data that underlie the results reported would be shared after de-identification Clinical Study Report,Study Protocol 11 months after study completion Those who need it for academic and research purposes
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