Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial
1 other identifier
interventional
108
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedDecember 10, 2013
December 1, 2013
3 months
November 25, 2013
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Scores on the Visual Analog Scale
Three months
Study Arms (4)
Placebo group
PLACEBO COMPARATORParacervical block plus lidocaine spray
ACTIVE COMPARATORLidocaine 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
ACTIVE COMPARATOR2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray
only lidocaine spray
ACTIVE COMPARATORparacervical block with saline solution plus 10% lidocaine spray
Interventions
Eligibility Criteria
You may qualify if:
- Age \>18 years Single Pregnancy \<7 weeks of gestation
You may not qualify if:
- Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gökhan Açmaz
Kayseri, 38010, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 10, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
December 10, 2013
Record last verified: 2013-12