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

Not Applicable

Active, not recruiting

• Conditions: Pain, Procedural; Lidocaine; Obstetric Surgical Procedures
• Interventions: Drug: 10 % lidocaine spray without adrenaline; Other: Placebo

• Registration Number: NCT06344637
• Lead Sponsor: UdonThani Hospital

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.

Study Timeline

• Study Start: 2023-12-14
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-30
• Last Update Submitted: 2024-03-30
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-05-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10% lidocaine spray without adrenaline	10 % lidocaine spray without adrenaline	4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration
Placebo	Placebo	4 puffs of normal saline apply on cervical os before manual vacuum aspiration

Primary Outcome Measures

Name	Time	Method
pain score after manual vauum aspiration	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	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

Trial Locations

Locations (1)

UdonThani Hospital; 🇹🇭 Udon Thani, UdonThani, Thailand