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

NCT01961752 | Completed

• 1 other identifier: 4-2012-0147
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastric Adenoma

Keywords

bupivacaine,; triamcinolone acetonide,; endoscopic; submucosal; dissection; Patients

Outcome Measures

Primary Outcomes (1)

• Present Pain Intensity (PPI) score

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

  at 6 hour after endoscopic submucosal dissection (ESD)

Study Arms (3)

Control group

PLACEBO COMPARATOR

Drug: Saline

Bupivacaine only group

EXPERIMENTAL

Drug: Bupivacaine + saline

Bupivacaine with triamcinolone group

ACTIVE COMPARATOR

Drug: Bupivacaine + triamcinolone acetonide

Interventions

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.

Control group

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 only group

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.

Bupivacaine with triamcinolone group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severnace Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Related Publications (2)

• 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.

  PMID: 19890693 BACKGROUND

• 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.

  PMID: 25060683 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Sodium Chloride; Bupivacaine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

KR (1)