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NCT06344637 Clinical Trial

Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration

Pain, Procedural Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06344637
Other study ID # 2566/081 I
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 14, 2023
Est. completion date July 30, 2024

Study information
Verified date March 2024
Source UdonThani Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 216
Est. completion date July 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 10 % lidocaine spray without adrenaline
Pateint with indication for manual vacuum aspiration aged between 20-60 years will received a standard injection of pethidine along with 1% lidocaine spray without adrenaline on cervical os to compare pain scores with placebo. Along with measuring side effects immediately and 30 minutes after receiving 1% lidocaine without adrenaline.
Other:
• Placebo
4 puffs of normal saline apply on cervical os before manual vacuum aspiration

Locations
Country Name City State
Thailand UdonThani Hospital Udon Thani UdonThani

Sponsors (1)
Lead Sponsor Collaborator
UdonThani Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain score during manual vauum aspiration 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 during surgery
Primary pain score after manual vauum aspiration 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 at 30 minutes postoperative
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