Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration

NCT06539143 | Completed Phase 4

• 1 other identifier: NHREC/16/05/22/209
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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 \[AEFUTHA\].

Conditions

Effect of Drug

Keywords

miscarriage; analgesia; manual vacuum aspiration

Outcome Measures

Primary Outcomes (1)

• Mean pain score using the Visual analogue scale

  The primary outcome measure is the mean pain score of the participants in the study groups.

  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

Study Arms (2)

GROUP A (Conscious Sedation)

ACTIVE COMPARATOR

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.

Drug: Lidocaine

GROUP B (The Paracervical Block)

EXPERIMENTAL

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.

Drug: Lidocaine

Interventions

Lidocaine DRUG

The Paracervical Block with lidocaine for manual vacuum aspiration

Also known as: Xylocaine

GROUP A (Conscious Sedation); GROUP B (The Paracervical Block)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This is by physical examination
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Darlington-Peter Chibuzor Ugoji: lead

Study Sites (1)

AEFUTHA

Abakaliki, Ebonyi State, 480101, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 15863551 BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous; Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• DARLINTON-PETER CHIBUZOR C UGOJI, MBBS

  Alex Ekwueme Federal University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: August 6, 2024
• Study Start: June 27, 2023
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)