The Efficacy of Topical Bupivacaine and Triamcinolone Acetonide Injection in the Relief of Pain After Endoscopic Submucosal Dissection for Gastric Neoplasia: A Randomized Double-blind, Placebo-controlled Trial

Not Applicable

Completed

• Conditions: Gastric Cancer; Gastric Adenoma
• Interventions: Drug: Saline; Drug: Bupivacaine + saline; Drug: Bupivacaine + triamcinolone acetonide

• Registration Number: NCT01961752
• Lead Sponsor: Yonsei University

Brief Summary

Although pain is a common complication of endoscopic submucosal dissection (ESD), management strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and in pain associated with surgery in clinical practice. Further, triamcinolone, a type of steroid, is often mixed with bupivacaine to lengthen the analgesic effect. The aim of this study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for abdominal pain relief and as a potential method of pain control after ESD for gastric neoplasia. We hypothesized that topical bupivacaine and/or triamcinolone acetonide injection after ESD would be effective for pain relief. For this, we designed randomized, double-blind, placebo-controlled trial. Eligible patients with early gastric neoplasm were randomized into one of three groups: bupivacaine (BV) only, bupivacaine with triamcinolone (BV-TA), or placebo. To evaluate the pain after ESD, the Present Pain Intensity (PPI) score and the Short-Form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain at 0, 6, 12 and 24 h after ESD.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-10
• Last Update Submitted: 2013-10-10
• Study First Posted: 2013-10-11
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Age, between 20 and 80
• Patients who were scheduled to undergo ESD for gastric epithelial neoplasm at Severance Hospital between July 2012 and April 2013

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Exclusion Criteria

• Not providing written informed consent
• A history of any cardiac arrhythmias
• Current or regular use of analgesic medication for other indications
• Known other disease such as peptic ulcer disease or reflux esophagitis which could induce upper gastrointestinal pain
• Multiple lesions requiring ESD in a single patient
• Evidence of infectious disease or antibiotics therapy within 7 days prior to enrollment
• Participation in another clinical trial within 30 days prior enrollment
• Current pregnancy or breast feeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	-
Bupivacaine only group	Bupivacaine + saline	-
Bupivacaine with triamcinolone group	Bupivacaine + triamcinolone acetonide	-

Primary Outcome Measures

Name	Time	Method
Present Pain Intensity (PPI) score	at 6 hour after endoscopic submucosal dissection (ESD)	Present Pain Intensity (PPI) score at 6 hour after endoscopic submucosal dissection (ESD) is assessed

Trial Locations

Locations (1)

Severnace Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of