Clinical trial NCT02037399: Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Gastric Cancer or Gastric Adenoma
Keywords: Endoscopic submucosal dissection
early gastric cancer
pain relief
intravenous dexamethasone
present pain intensity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.


Eligibility criteria: Inclusion Criteria:

* 20 years of age or older
* pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
* patients who gave written informed consent from patients or responsible family members.

Exclusion Criteria:

* patients who take pain killer within 48 hours or regularly at enrollment
* confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
* multiple gastric lesions for ESD
* history of gastric surgery at enrollment
* severe underlying disease including infection, cardiopulmonary disease, and diabetes.

Primary outcomes:
measure: present pain intensity (PPI)
timeFrame: at 6 hours after ESD
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
citation: Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.
citation: De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
citation: 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.