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

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ClinicalTrials.gov Identifier: NCT01961752

Recruitment Status : Completed

First Posted : October 11, 2013

Last Update Posted : October 11, 2013

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Sponsor:

Information provided by (Responsible Party):

Yonsei University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer Gastric Adenoma	Drug: Saline Drug: Bupivacaine + saline Drug: Bupivacaine + triamcinolone acetonide	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	111 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	July 2012
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Bupivacaine hydrochloride Bupivacaine

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Control group	Drug: Saline 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.
Experimental: Bupivacaine only group	Drug: Bupivacaine + saline 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.
Active Comparator: Bupivacaine with triamcinolone group	Drug: Bupivacaine + triamcinolone acetonide 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961752

Locations

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Korea, Republic of
Severnace Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01961752
Other Study ID Numbers:	4-2012-0147
First Posted:	October 11, 2013 Key Record Dates
Last Update Posted:	October 11, 2013
Last Verified:	October 2013

Keywords provided by Yonsei University:


bupivacaine, triamcinolone acetonide, endoscopic	submucosal dissection Patients

Additional relevant MeSH terms:

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Adenoma Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Bupivacaine Triamcinolone diacetate Anesthetics, Local Anesthetics Central Nervous System Depressants	Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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