Use of Lidocaine in Endoscopic Submucosal Dissection

Not Applicable

Completed

• Conditions: Gastric Neoplasm
• Interventions: Drug: Lidocaine 1%; Drug: Normal saline

• Registration Number: NCT02543411
• Lead Sponsor: Severance Hospital

Brief Summary

The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.

The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Primary Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm

Exclusion Criteria

1. Allergy to lidocaine
2. Chronic pain
3. Chronic abuse of opioid or NSAID
4. Atrioventricular conductance block
5. Liver dysfunction
6. Renal dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine 1%	Administration of lidocaine 1%
Control group	Normal saline	Administration of normal saline

Primary Outcome Measures

Name	Time	Method
Fentanyl consumption during sedation	During sedation, an expected average of 40 minutes

Secondary Outcome Measures

Name	Time	Method
Pain intensity measured by numerical rating scale	30 min, 6 hr, and 24 hr after procedure	0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale)
Incidence of nausea and vomiting	Up to 24 hours	Nausea requiring antiemetics and retching and/or vomiting

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of