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
Condition: Gastric Cancer; Gastric Adenoma
MeSH terms: Adenoma
Study type: Interventional

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.
    


Intervention name(s): Saline; Bupivacaine + saline; Bupivacaine + triamcinolone acetonide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bupivacaine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bupivacaine,; triamcinolone acetonide,; endoscopic; submucosal; dissection; Patients