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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01961752

Collaborator

(none)

111

Enrollment

Location

Arms

Duration (Months)

12.3

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

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.

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 [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

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.