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

Pain Score Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007408
• Other study ID #: KERH
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: December 5, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Score

Intervention

Drug:
• Paracervical block

• Lidocaine spray

• Paracervical block + lidocaine spray

Locations

Country	Name	City	State
Turkey	Gökhan Açmaz	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Visual Analog Scale		Three months	Yes