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

Not Applicable

Completed

• Conditions: Pain Score
• Interventions: Drug: Paracervical block + lidocaine spray; Drug: Paracervical block; Drug: Lidocaine spray

• Registration Number: NCT02007408
• Lead Sponsor: Kayseri Education and Research Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-11-25
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-05
• Last Update Submitted: 2013-12-05
• Study First Posted: 2013-12-10
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical block plus lidocaine spray	Paracervical block + 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
paracervical block plus isotonic saline spray	Paracervical block	2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray
only lidocaine spray	Lidocaine spray	paracervical block with saline solution plus 10% lidocaine spray

Primary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale	Three months

Trial Locations

Locations (1)

Gökhan Açmaz; 🇹🇷 Kayseri, Turkey