Clinical trial

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

Name

2566/081 I

Description

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

Trial arms

Trial start

2023-12-14

Estimated PCD

2024-05-30

Trial end

2024-07-30

Status

Active (not recruiting)

Treatment

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.

Arms:

10% lidocaine spray without adrenaline

Other names:

10% Xylocaine spray

Placebo

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

Arms:

Placebo

Size

216

Primary endpoint

pain score during manual vauum aspiration

during surgery

pain score after manual vauum aspiration

at 30 minutes postoperative

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 216, 'type': 'ACTUAL'}}

Updated at

2024-04-03

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication

Obstetric Surgical Procedures