Skip to content

The efficacy of topical bupivacaine and triamcinolone acetonide submucosal injection for pain relief after endoscopic submucosal dissection: a randomized double-blind, placebo-controlled multi-center trial

The efficacy of topical bupivacaine and triamcinolone acetonide submucosal injection for pain relief after endoscopic submucosal dissection: a randomized double-blind, placebo-controlled multi-center trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002894
Enrollment
86
Registered
2018-05-24
Start date
2014-10-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : We used 4 ml of 0.5&#37
bupivacaine 20mg/4ml/A (20mg) (AstraZeneca, Seoul, Korea), 15 ml of normal saline, 0.5 ml of 0.8&#37
indigo-carmine dye 40mg/5ml/A (4mg) (Korea United pharm, Seoul, Korea), and 0.5 ml of 0.1&#37
epinephrine 1mg/ml/A (0.5mg) (Danhan pharm, Seoul, Korea) for the BP group in this study. On the other hand, we used conventional solution consisting of 19 ml of normal saline, 0.5 ml of 0.8&#37
indigo-carmine dye, and 0.5 ml of 0.1&#37
epinephrine for the placebo group.

Sponsors

Hallym University Medical Center-Dongtan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We prospectively evaluated consecutive patients with ages of 20 or older who were scheduled to undergo ESD for pathologically diagnosed or clinically suspected gastric adenoma or cancer at Hallym medical center.

Exclusion criteria

Exclusion criteria: (1) declining to provide informed consent; (2) American Society of Anesthesiology risk Class 3 or higher; (3) severe hepatic disease or cardiopulmonary or renal dysfunction; (4) current analgesics including non-steroidal anti-inflammatory drug use during the preceding week; (5) allergy to bupivacaine or other amide-type local anesthesia; (6) confirmation of any other disease that could induce abdominal pain similar with post-ESD pain; (7) presence of multiple lesions requiring endoscopic resection in one patient; (8) current pregnancy or breast feeding; (9) impossible to assess pain such as severe psychiatric or neurologic disease.

Design outcomes

Primary

MeasureTime frame
the visual analogue scale

Secondary

MeasureTime frame
the visual analogue scale;short-form McGill pain (SF-MP) score;short-form McGill pain (SF-MP) score;procedure related adverse events

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026