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Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial

NCT ID: NCT02007408

Last Updated: 2013-12-10

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

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.

Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).

Detailed Description

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Conditions

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Pain Score

Keywords

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abortion analgesia paracervical block lidocaine spray

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo group

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Paracervical block plus lidocaine spray

Lidocaine injection+Lidocaine spray received PCB with 2 ampoules of lidocaine solution plus 2 pumps (20 mg=2 pumps) of 10% lidocaine spray

Group Type ACTIVE_COMPARATOR

Paracervical block + lidocaine spray

Intervention Type DRUG

paracervical block plus isotonic saline spray

2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray

Group Type ACTIVE_COMPARATOR

Paracervical block

Intervention Type DRUG

only lidocaine spray

paracervical block with saline solution plus 10% lidocaine spray

Group Type ACTIVE_COMPARATOR

Lidocaine spray

Intervention Type DRUG

Interventions

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Paracervical block

Intervention Type DRUG

Lidocaine spray

Intervention Type DRUG

Paracervical block + lidocaine spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Age \>18 years Single Pregnancy \<7 weeks of gestation

Exclusion Criteria

Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gökhan Açmaz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gökhan Açmaz

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KERH

Identifier Type: -

Identifier Source: org_study_id