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.: PACTR202108841661192 Date of Approval: 23/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomized Controlled Trial to Compare the Analgesic Efficacy and Safety of Paracervical Block and Conscious Sedation in the Surgical Evaluation of the Uterus Following First Trimester Incomplete Miscarriages
Official scientific title Single Centre Open Label Randomized Controlled Trial (RCT) to Randomized Controlled Trial to Compare the Analgesic Efficacy and Safety of Paracervical Block and Conscious Sedation in the Surgical Evaluation of the Uterus Following First Trimester Incomplete Miscarriages
Brief summary describing the background and objectives of the trial Miscarriages are a frequent complication of first trimester pregnancies and often require evacuation to prevent retention of products of conception. Evacuation of the uterus in incomplete miscarriage is associated with different levels of pain, thus, pain relief is necessary for evacuation. Pain reliefs can be non pharmacological or pharmacological (local anaesthesia, sedation, and general anaesthesia). Due to the systemic effects of some of the agents used as pain relief during evacuation and the paucity of health staff and equipments to monitor, there is need to compare the analgesic efficacy and side effect profile of paracervical block and conscious sedation in the surgical management of first trimester incomplete miscarriage. To compare the efficacy of paracervical block and conscious sedation in the surgical evacuation of the uterus with manual vacuum aspiration among women presenting at Alex Ekwueme Federal Teaching Hospital Abakaliki with first trimester incomplete miscarriages.  To compare the side effects profile of paracervical block and conscious sedation in the surgical evacuation of the uterus with manual vacuum aspiration among women presenting at Alex Ekwueme Federal Teaching Hospital Abakaliki with first trimester incomplete miscarriages.  To compare maternal satisfaction of paracervical block and conscious sedation in the surgical evacuation of the uterus with manual vacuum aspiration among women presenting at Alex Ekwueme Federal Teaching Hospital Abakaliki with first trimester incomplete miscarriages.  To compare the preference of physicians between paracervical block and conscious sedation in the surgical evacuation of the uterus with manual vacuum aspiration among 19 women presenting at Alex Ekwueme Federal Teaching Hospital Abakaliki with first trimester incomplete miscarriages.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
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 26/01/2020
Actual trial start date 26/09/2020
Anticipated date of last follow up 20/08/2021
Actual Last follow-up date 25/09/2021
Anticipated target sample size (number of participants) 162
Actual target sample size (number of participants) 162
Recruitment status Closed to recruitment,follow-up continuing
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 Participants allocated to group A received 4 ml of 1% lidocaine, for each block at the 4 and 8’0 clock positions and 2 ml at the anterior lip of the cervix. once Participants allocated to group A received 4 ml of 1% lidocaine, for each block at the 4 and 8’0 clock positions and 2 ml at the anterior lip of the cervix. Participants in this group were placed in the lithotomy position, the perineum was cleaned with a Savlon swab, and the patient was draped. Her bladder was emptied. A Cusco’s speculum was inserted into the vagina to allow complete visualization of the cervix. Products of conception and blood obscuring vision were wiped away. The 4 o’clock and 8 o’clock positions at the junction of the cervix and vagina were identified. After which, a 10 ml syringe was used to draw up 10 ml of 1% lidocaine solution (equivalent to 100 mg). A 22 gauge spinal needle was connected to the syringe and then 2 ml was injected superficially at the anterior lip of the cervix after about 2 minutes, it was held by the sponge holding forceps at the 12 o’clock position. Slight traction was applied to move the cervix in order to define the transition of smooth cervical epithelium to vagina tissue. This reflection marks the line of injection. 4 ml each was injected at the 4 o’clock and 8 o’clock positions slowly for 60 seconds at a depth of 3-7 mm. The syringe’s plunger was withdrawn first to ensure that the needle was not in a vessel. Once the block was given, the clinician withdrew the Cusco’s speculum and waited for five minutes before commencing the procedure. Preoperative vital signs before, during, 10 minutes and 2 hours after the procedure was checked and recorded. Also, the maximum pulse rate and minimum oxygen saturation during the procedure were recorded. 81
Control Group Conscious Sedation Participants allocated to group B received intravenous 30 mg pentazocin and 10 mg diazepam for conscious sedation. once Participants allocated to group B received intravenous 30 mg pentazocine and 10 mg diazepam for conscious sedation. There was a preoperative assessment to ascertain the participant’s fitness as well as if she met the inclusion criteria. Then the preoperative vital signs which included blood pressure, pulse rate, and respiratory rate were measured and recorded. A vein above the wrist joint was selected and cleaned with a spirit swab. Intravenous access was secured with an 18G cannula and 10 mg diazepam were administered first with a syringe over one minute. Thereafter, 30 mg pentazocine was administered intravenously, over one minute, and a latency period of 2 minutes was allowed before the commencement of the procedure for the onset of analgesic function. The participant’s pulse, blood pressure, and oxygen saturation were monitored all through the procedure using a pulse oximeter and the values of blood pressures, maximum pulse rate, and lowest partial pressure of oxygen were recorded. The vital signs were measured after the procedure. 81 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Incomplete miscarriage ≤13 weeks of gestation. Stable patients Patients with known history of allergy to the drugs. Patients with infection at the site of the block. Psychiatric or neurological diseases. Presence of active pelvic inflammatory disease. Adult: 19 Year-44 Year 18 Year(s) 45 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 26/02/2020 Alex Ekwueme Federal University Teaching Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
8 Ejiofor street Abakaliki Abakaliki 480 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was assessment of the efficacy of analgesia when paracervical block was compared with conscious sedation, also for the requirement of supplementary analgesia/anesthesia intraoperatively. 10 minutes, 2 hours and 24 hours
Secondary Outcome The Secondary outcome measures were the incidence of complications, postoperative activity, the feasibility of the procedure to be done for daycare and participant’s satisfaction. It also included side effects of different agents in the surgical evacuation of incomplete miscarriage and maternal satisfaction. 10 minutes, 2 hours, 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR SOPHIA NNENA 8 EJIOFOR STREET ABAKALIKI ABAKALIKI 480 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SOPHIA NNENNA NWEKE 8 EJIOFOR STREET ABAKALIKI ABAKALIKI 480 Nigeria Individual
Secondary Sponsor Justus N Eze 8 Ejiofor Street Abakaliki Abakaliki 480 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Ewah R.L 8 EJIOFOR STREET ABAKALIKI ABAKALIKI 480 Nigeria
Justus N Eze 8 Ejiofor street Abakaliki Abakaliki 480 Nigeria
Chidebe C Anikwe 8 Ejiofor Street Abakaliki Abakaliki 480 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sophia Nnenna Nweke ninasophia4iyke@gmail.com +2348035489950 8 Ejiofor Street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Post part 2 senior registrar
Role Name Email Phone Street address
Scientific Enquiries Justus Eze justndueze@gmail.com +2348033183443 8 Ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Richard Ewah drewah08@yahoo.com +2348037468896 8 Ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Consultant Anaethetist
Role Name Email Phone Street address
Public Enquiries Chidebe Anikwe drchideanikwechristian@gmail.com +2348064165965 8 Ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Consultant Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
none 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