NCT02039661

Brief Summary

The effect of lidocaine spray on pain relief during endometrial sampling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

January 16, 2014

Last Update Submit

January 16, 2014

Conditions

Pain

Keywords

Curettage;Pain Score

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Patients were asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring was performed at 3 different time points: immediately before to the procedure, during the procedure (immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients were asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.

    3 months

Study Arms (2)

Lidocaine Spray

ACTIVE COMPARATOR
Drug: Lidocaine Spray

Placebo

PLACEBO COMPARATOR

These patients received placebo spray.

Drug: Placebo

Interventions

Lidocaine SprayDRUG

These patients received 2 puff lidocaine spray

Lidocaine Spray
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age\>18 years no allergy Patients with abnormal uterine bleeding

You may not qualify if:

  • cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Education and Research Hospital of Medicine

Kayseri, 38210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gökhan Açmaz, MD

    Kayseri Education and Research Hospital of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

TU(1)