NCT06539143

Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration

Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration for First Trimester Incomplete Miscarriage in Abakaliki: A Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Darlington-Peter Chibuzor Ugoji · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Effect of Drug

Interventions

Type	Name	Description
DRUG	Lidocaine	The Paracervical Block with lidocaine for manual vacuum aspiration

Timeline

• Start date: 2023-06-27
• Primary completion: 2023-09-26
• Completion: 2023-09-26
• First posted: 2024-08-06
• Last updated: 2024-08-06

Locations

1 site across 1 country: Nigeria