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
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Cancer; Gastric Adenoma
Intervention: Saline (Drug); Bupivacaine + saline (Drug); Bupivacaine + triamcinolone acetonide (Drug)
Phase: N/A
Status: Completed
Sponsored by: Yonsei University
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Present Pain Intensity (PPI) score
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Severnace Hospital, Yonsei University Health System, Seoul 120-752, Korea, Republic of
Additional Information
Related publications: Kiriyama S, Oda I, Nishimoto F, Mashimo Y, Ikehara H, Gotoda T. Pilot study to assess the safety of local lidocaine injections during endoscopic submucosal dissection for early gastric cancer. Gastric Cancer. 2009;12(3):142-7. doi: 10.1007/s10120-009-0514-y. Epub 2009 Nov 5.
Starting date: July 2012
Last updated: October 10, 2013
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