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

Study Overview
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Brief Summary
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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.

Conditions
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Gastric Cancer, Gastric Adenoma

Intervention / Treatment
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* Drug: Saline
* Drug: Bupivacaine + saline
* Drug: Bupivacaine + triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br> | Drug: Saline<br>* All patients undergo endoscopic submucosal dissection. The local injection was performed using 15 ml saline just before the ESD was finished. It was delivered through the endoscopy suite and injected into the cautery ulcer base in aliquots of 1 mL at equal intervals (1 cm apart). The number of injections per patient was dependent on the size of resection.<br>|
| Experimental: Bupivacaine only group<br> | Drug: Bupivacaine + saline<br>* All patients undergo endoscopic submucosal dissection. The local injection was performed using a mixture of 10 ml bupivacaine (total 50 mg) and 5 ml saline just before the ESD was finished. It was delivered through the endoscopy suite and injected into the cautery ulcer base in aliquots of 1 mL at equal intervals (1 cm apart). The number of injections per patient was dependent on the size of resection.<br>|
| Active Comparator: Bupivacaine with triamcinolone group<br> | Drug: Bupivacaine + triamcinolone acetonide<br>* All patients undergo endoscopic submucosal dissection. The local injection was performed using a mixture of 10ml bupivacaine (total 50 mg) and 5 ml triamcinolone acetonide (total 50 mg) just before the ESD was finished. It was delivered through the endoscopy suite and injected into the cautery ulcer base in aliquots of 1 mL at equal intervals (1 cm apart). The number of injections per patient was dependent on the size of resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Present Pain Intensity (PPI) score | Present Pain Intensity (PPI) score at 6 hour after endoscopic submucosal dissection (ESD) is assessed | at 6 hour after endoscopic submucosal dissection (ESD) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bupivacaine,, triamcinolone acetonide,, endoscopic, submucosal, dissection, Patients