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

Yonsei University

Status: Completed

Conditions: Gastric Cancer; Gastric Adenoma

Treatments: Drug: Bupivacaine + saline; Drug: Saline; Drug: Bupivacaine + triamcinolone acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT01961752

4-2012-0147

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Treatment:

Drug: Saline

Bupivacaine only group

Experimental group

Treatment:

Drug: Bupivacaine + saline

Bupivacaine with triamcinolone group

Active Comparator group

Treatment:

Drug: Bupivacaine + triamcinolone acetonide