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Clinical Trials/NCT02007408
NCT02007408
Completed
Not Applicable

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

Kayseri Education and Research Hospital1 site in 1 country108 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Paracervical block + lidocaine spray
Conditions
Pain Score
Sponsor
Kayseri Education and Research Hospital
Enrollment
108
Locations
1
Primary Endpoint
Pain Scores on the Visual Analog Scale
Status
Completed
Last Updated
12 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kayseri Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gökhan Açmaz

MD

Kayseri Education and Research Hospital

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Paracervical block + lidocaine spray

paracervical block plus isotonic saline spray

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

Intervention: Paracervical block

only lidocaine spray

paracervical block with saline solution plus 10% lidocaine spray

Intervention: Lidocaine spray

Outcomes

Primary Outcomes

Pain Scores on the Visual Analog Scale

Time Frame: Three months

Study Sites (1)

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