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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric Adenoma Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severnace Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline

Drug

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.

Bupivacaine + saline

Drug

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.

Bupivacaine + triamcinolone acetonide

Drug

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.

Primary outcomes

Present Pain Intensity (PPI) score

Time frame: at 6 hour after endoscopic submucosal dissection (ESD)

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Oct 11, 2013
Registry last updated: Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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