Ropivacaine For Post-POEM Pain Control

Achalasia Clinical Trial

Official title:

Ropivacaine For Post-POEM Pain Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702647
• Other study ID #: DMED -2186-18
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: January 18, 2021

Study information

• Verified date: January 2021
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.

Description:

POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax. Consequently, patients experience difficulty swallowing, reflux, and weight loss. Treatment options for achalasia are generally divided into 2 categories: A) treatment with medication, or B) treatment via a procedure. Medical treatment is generally reserved for patients to unwell to undergo procedures as the efficacy is low. Additionally, patients tend to experience many side-effects. There are also procedural options used to treat achalasia which include surgical myotomy and POEM. The POEM procedure is advantageous because it is less invasive, but is at least as equally effective for symptomatic relief when compared to the surgical myotomy. The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms. At the conclusion of the procedure, clips are placed in the esophagus to close the incision. Currently, patients are given intravenous ketorolac, oral viscous lidocaine and narcotic analgesics as needed to manage post-operative pain. This study, however, seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications. Patients consented to participate in the study will be randomized to receive either ropivacaine (intervention group) or saline (control group). Pain will be assessed at 0.5, 1, 2, 4, and 6 hours post-admission to the recovery unit using validated pain scales. Additionally, the Quality of Recovery (QoR-15) patient survey, will be completed prior to discharge. This measure will capture the patient's initial post-operative health condition and help capture the overall patient experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 18, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older undergoing POEM procedure
• Able to provide written informed consent
• Fluent and literate in English

Exclusion Criteria:

• Patients with known adverse reactions to local anesthetics and NSAIDs (GFR<50)
• Patients with chronic pain taking regular analgesics or narcotics (requiring daily opioid therapy > 30 mg morphine or equivalents)
• Patients unable to give informed consent

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Drug:
• Ropivacaine
30mL of 0.2% Ropivacaine placed in the POEM tunnel
• Normal saline
30mL of normal saline placed in the POEM tunnel

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawrence Charles Hookey

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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Castagliuolo I, Brun P, Costantini M, Rizzetto C, Palù G, Costantino M, Baldan N, Zaninotto G. Esophageal achalasia: is the herpes simplex virus really innocent? J Gastrointest Surg. 2004 Jan;8(1):24-30; discussion 30. — View Citation

Clark SB, Rice TW, Tubbs RR, Richter JE, Goldblum JR. The nature of the myenteric infiltrate in achalasia: an immunohistochemical analysis. Am J Surg Pathol. 2000 Aug;24(8):1153-8. — View Citation

de La Coussaye JE, Eledjam JJ, Brugada J, Sassine A. [Cardiotoxicity of local anesthetics]. Cah Anesthesiol. 1993;41(6):589-98. Review. French. — View Citation

Goyal RK, Chaudhury A. Pathogenesis of achalasia: lessons from mutant mice. Gastroenterology. 2010 Oct;139(4):1086-90. doi: 10.1053/j.gastro.2010.08.013. Epub 2010 Aug 25. — View Citation

Goyal RK, Chaudhury A. Physiology of normal esophageal motility. J Clin Gastroenterol. 2008 May-Jun;42(5):610-9. doi: 10.1097/MCG.0b013e31816b444d. Review. — View Citation

Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30. — View Citation

Kallel-Sellami M, Karoui S, Romdhane H, Laadhar L, Serghini M, Boubaker J, Lahmar H, Filali A, Makni S. Circulating antimyenteric autoantibodies in Tunisian patients with idiopathic achalasia. Dis Esophagus. 2013 Nov-Dec;26(8):782-7. doi: 10.1111/j.1442-2050.2012.01398.x. Epub 2012 Sep 4. — View Citation

Niwamoto H, Okamoto E, Fujimoto J, Takeuchi M, Furuyama J, Yamamoto Y. Are human herpes viruses or measles virus associated with esophageal achalasia? Dig Dis Sci. 1995 Apr;40(4):859-64. — View Citation

Robertson CS, Martin BA, Atkinson M. Varicella-zoster virus DNA in the oesophageal myenteric plexus in achalasia. Gut. 1993 Mar;34(3):299-302. — View Citation

Sadowski DC, Ackah F, Jiang B, Svenson LW. Achalasia: incidence, prevalence and survival. A population-based study. Neurogastroenterol Motil. 2010 Sep;22(9):e256-61. doi: 10.1111/j.1365-2982.2010.01511.x. Epub 2010 May 11. — View Citation

Samo S, Carlson DA, Gregory DL, Gawel SH, Pandolfino JE, Kahrilas PJ. Incidence and Prevalence of Achalasia in Central Chicago, 2004-2014, Since the Widespread Use of High-Resolution Manometry. Clin Gastroenterol Hepatol. 2017 Mar;15(3):366-373. doi: 10.1016/j.cgh.2016.08.030. Epub 2016 Aug 28. — View Citation

Schlottmann F, Herbella F, Allaix ME, Patti MG. Modern management of esophageal achalasia: From pathophysiology to treatment. Curr Probl Surg. 2018 Jan;55(1):10-37. doi: 10.1067/j.cpsurg.2018.01.001. Epub 2018 Jan 31. Review. Erratum in: Curr Probl Surg. 2019 Feb;56(2):91. — View Citation

Schlottmann F, Luckett DJ, Fine J, Shaheen NJ, Patti MG. Laparoscopic Heller Myotomy Versus Peroral Endoscopic Myotomy (POEM) for Achalasia: A Systematic Review and Meta-analysis. Ann Surg. 2018 Mar;267(3):451-460. doi: 10.1097/SLA.0000000000002311. — View Citation

Scott DB, Lee A, Fagan D, Bowler GM, Bloomfield P, Lundh R. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg. 1989 Nov;69(5):563-9. — View Citation

Ujiki MB, Yetasook AK, Zapf M, Linn JG, Carbray JM, Denham W. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. 2013 Oct;154(4):893-7; discussion 897-900. doi: 10.1016/j.surg.2013.04.042. — View Citation

Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-POEM pain level	To assess the effect of the intervention/placebo on pain 6-hours post-POEM as assessed via the Numeric Rating Scale (NRS): The patient will be asked to rate their pain on a scale of 0-10, 0 representing no pain, and 10 representing the worst pain they have ever felt in their life.	6 hours post-POEM procedure
Secondary	Post-POEM pain level	Assessing pain scores at 0, 0.5, 1, 2, 4 hours post-POEM and on discharge	0, 0.5, 1, 2, 4 hours post-POEM procedure
Secondary	Quality of Recovery (QoR-15) score on the day of discharge	Quality of Recovery-15 score: This survey captures patient's initial post-operative health condition and their overall patient experience. The patient will be asked to rate various emotional and physical aspects of their post-operative condition on a scale of 0-10. 0 will represent an emotion or activity experienced or accomplished none of the time, and 10 will represent an emotion or activity accomplished all of the time. Scores are summed; higher scores indicate a more optimal post-operative condition.	Assessed up to 24 hours post-POEM procedure
Secondary	Post-POEM analgesic	The requirement of post-POEM analgesic	0 -6 hours post-procedure
Secondary	Adverse Events	Adverse events in hospital	Assessed up to 24 hours post-POEM procedure
Secondary	Fentanyl consumption	Intraprocedural fentanyl consumption	Intra-procedure
Secondary	Repeatability of procedure	Patient's willingness to have the procedure done on an outpatient basis: Patients will be asked if they are "willing" or "not willing" to have the procedure done on an outpatient basis.	Assessed 24 hours post-POEM procedure