Clinical trial NCT01961752: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Gastric Adenoma
Keywords: bupivacaine,
triamcinolone acetonide,
endoscopic
submucosal
dissection
Patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Present Pain Intensity (PPI) score
timeFrame: at 6 hour after endoscopic submucosal dissection (ESD)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severnace Hospital, Yonsei University Health System
Study officials:
References:
citation: 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.
citation: Kim B, Lee H, Chung H, Park JC, Shin SK, Lee SK, Lee YC. 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. Surg Endosc. 2015 Mar;29(3):714-22. doi: 10.1007/s00464-014-3730-4. Epub 2014 Jul 25.