Clinical trial NCT06539143: Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration
Official title: Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration for First Trimester Incomplete Miscarriage in Abakaliki: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Effect of Drug
Keywords: miscarriage
analgesia
manual vacuum aspiration
Lead sponsor: Alex Ekwueme Federal University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a clinical equivalence randomized controlled trial comparing the efficacy of conscious sedation and paracervical block among women selected for manual vacuum aspiration following incomplete miscarriages in first trimester in Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AEFUTHA), Ebonyi State.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality. Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki \[AEFUTHA\].

Detailed description: SUMMARY

Background:

First trimester pregnancy losses are estimated to occur in 14-19% of all clinically confirmed pregnancies and account for about 80% of all the pregnancy losses. Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality.

Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. In my center, conscious sedation is mostly used but because of the pronounced systemic side effect of drowsiness, weakness etc, there is a shift to paracervical block hence this study.

Objectives:

The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki \[AEFUTHA\].

Methodology:

This was a randomized control trial equivalent study that compared the analgesia from conscious sedation with that of the paracervical block in women selected for manual vacuum aspiration following first trimester incomplete miscarriage in AEFUTHA. Patients were categorized into groups: A and B. Those in group A received conscious sedation using intravenous diazepam 10 mg and intravenous pentazocine 30 mg stat while those in the other group B received paracervical block via the use of 10ml of 1% lidocaine with 4ml at 4:00 clock and 8:00 clock respectively and 2ml at the anterior lip of the cervix. After analgesic effect has occurred, manual vacuum aspiration was done and there after pain assessment was be carried out at 10 mins, 2 hours, 6 hours, 12 hours and 24 hours respectively. The vital signs and oxygen saturation pre and post operatively were monitored with chart kept for analysis.

Analysis:

The data were analyzed using Spss, version 28.0 (2022). Continuous variables were compared with t- test while categorical variables were compared with Chi- square and the p-value determined. P- value less than 0.05 was taken to be statistically significant.

Eligibility criteria: Inclusion Criteria:

* - Between the ages of 18- 45 years.
* Spontaneous incomplete miscarriage at less than 13 weeks.
* Not allergic to drugs for the study
* Patients that give consent

Exclusion Criteria:

* - Patients who do not consent to MVA \[ Manual vacuum aspiration\].
* Those with known allergy history to the drug agents.
* Those with septic incomplete miscarriage.
* Patients with infection at the cervical blocking sites.
* Those with active pelvic inflammatory disease.
* Patients with neurological or psychiatric disease.
* Incomplete miscarriage at greater than 13 weeks.

Primary outcomes:
measure: Mean pain score using the Visual analogue scale
timeFrame: Pain and side effects experienced following the use of the analgesic agents at about 10 minutes, 2 hours, 6 hours, 12 hours and 24 hours following the procedure was noted. Higher score showed more pain and lower score showed lower pain
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: AEFUTHA
state: Ebonyi
Study officials:
affiliation: Alex Ekwueme Federal University Teaching Hospital
name: DARLINTON-PETER CHIBUZOR C UGOJI, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sotiriadis A, Makrydimas G, Papatheodorou S, Ioannidis JP. Expectant, medical, or surgical management of first-trimester miscarriage: a meta-analysis. Obstet Gynecol. 2005 May;105(5 Pt 1):1104-13. doi: 10.1097/01.AOG.0000158857.44046.a4.