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

NCT06344637 | Active Not Recruiting

• 1 other identifier: 2566/081 I
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Procedural; Lidocaine; Obstetric Surgical Procedures

Keywords

manual vacuum aspiration; pain score; Lidocaine spray

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

10% lidocaine spray without adrenaline

EXPERIMENTAL

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

Drug: 10 % lidocaine spray without adrenaline

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

10 % lidocaine spray without adrenaline DRUG

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.

Also known as: 10% Xylocaine spray

10% lidocaine spray without adrenaline

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UdonThani Hospital: lead

Study Sites (1)

UdonThani Hospital

Udon Thani, UdonThani, 41000, Thailand

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• PATTARIKAN MANAYING

  UdonThani Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 3, 2024
• Study Start: December 14, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)