Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2023-09-26

Brief Summary

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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 \[AEFUTHA\].

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Detailed Description

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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

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Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GROUP A (Conscious Sedation)

30mg of pentazocine was given intravenously, over one minute and a latency period of about 2 minutes was allowed before starting the procedure for analgesic function to take effect.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

The Paracervical Block with lidocaine for manual vacuum aspiration

GROUP B (The Paracervical Block)

Received 10 ml of 1% lidocaine, for the blocks with 4ml at 4 O' clock and 8 O'clock positions and 2 ml at the anterior cervical lip.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

The Paracervical Block with lidocaine for manual vacuum aspiration

Interventions

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Lidocaine

The Paracervical Block with lidocaine for manual vacuum aspiration

Intervention Type DRUG

Other Intervention Names

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Xylocaine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes