Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration

Phase 4

Completed

• Conditions: Effect of Drug
• Interventions: Drug: Lidocaine

• Registration Number: NCT06539143
• Lead Sponsor: Darlington-Peter Chibuzor Ugoji

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 ...

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-06-27
• Primary Completion: 2023-09-26
• Study Completion: 2023-09-26
• Study First Submitted: 2024-04-14
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP B (The Paracervical Block)	Lidocaine	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 A (Conscious Sedation)	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Mean pain score using the Visual analogue scale	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	The primary outcome measure is the mean pain score of the participants in the study groups.

Trial Locations

Locations (1)

AEFUTHA; 🇳🇬 Abakaliki, Ebonyi, Nigeria