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Clinical Trials/NCT06344637
NCT06344637
Active, not recruiting
Not Applicable

Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration : A Randomized Controlled Trial

UdonThani Hospital1 site in 1 country216 target enrollmentDecember 14, 2023

Overview

Phase
Not Applicable
Intervention
10 % lidocaine spray without adrenaline
Conditions
Pain, Procedural
Sponsor
UdonThani Hospital
Enrollment
216
Locations
1
Primary Endpoint
pain score after manual vauum aspiration
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration

Detailed Description

This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.

Registry
clinicaltrials.gov
Start Date
December 14, 2023
End Date
July 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Metha Songthamwat

Principal investigator

UdonThani Hospital

Eligibility Criteria

Inclusion Criteria

  • female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia

Exclusion Criteria

  • patient with allergic to lidocaine or history of allergic to lidocaine
  • patient with reproductive and urinary infection
  • patient with abnormal vital sign
  • patient with abnormal kidney and liver function test

Arms & Interventions

10% lidocaine spray without adrenaline

4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration

Intervention: 10 % lidocaine spray without adrenaline

Placebo

4 puffs of normal saline apply on cervical os before manual vacuum aspiration

Intervention: Placebo

Outcomes

Primary Outcomes

pain score after manual vauum aspiration

Time Frame: at 30 minutes postoperative

The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain

pain score during manual vauum aspiration

Time Frame: during surgery

The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain

Study Sites (1)

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