Post Operative Pain Control of POEM Procedure

NCT04177342 | Unknown Phase 4

• 1 other identifier: POEM pain control
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

Peroral endoscopic myotomy (POEM) is a minimally invasive treatment for esophageal achalasia with a natural orifice transluminal endoscopic procedure and far less invasive than the standard surgical or laparoscopic Heller myotomy (LHM). Less is known about the postoperative pain after POEM and the minor surgery trauma, short length of stay may lead to underestimation of postoperative pain control. We tend to observe the pain status after the POEM surgery under the empirical treatment in our center, and find a proper intra-operative way of pain control to solve the post-operative pain and seek the possible influence factors of postoperative pain.

Conditions

Achalasia

Keywords

achalasia; Peroral endoscopic myotomy; post-operative pain

Outcome Measures

Primary Outcomes (3)

• post-operative pain condition

  use Visual Analogue Scale/Score(0-10) to record post operative pain

  36 hours after the POEM surgery

• post-operative PCA usage volumn

  record PCA usage volumn(ml) to see the dosage of opiods used after the surgery

  36 hours after the POEM surgery

• post-operative sleep quality

  Postoperative sleep quality was investigated with a self-reported sleep questionnaire including 6 yes/no questions(0-6) with full score 6 represented the worst sleep

  48 hoursafter the surgery

Secondary Outcomes (1)

• chronic pain condition

  28 days after discharge

Study Arms (2)

fentanyl

ACTIVE COMPARATOR

the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group

Drug: Fentanyl

oxycodone

EXPERIMENTAL

the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group

Drug: Oxycodone

Interventions

Fentanyl DRUG

the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group

fentanyl

Oxycodone DRUG

the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group

oxycodone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Achalasia patients undergoing elective POEM surgery
• age 18-80
• BMI 18-30 kg/m2

You may not qualify if:

• Patient refusal
• ASA≥ 3
• abnormality of liver and kidney function in patients
• patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively
• patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme
• patients with chronic pain before operation with analgesic drugs

Sponsors & Collaborators

• Chen Wannan: lead

MeSH Terms

Conditions

Esophageal Achalasia; Pain, Postoperative

Interventions

Fentanyl; Oxycodone

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Wannan Chen, MD

  Shanhai Zhongshan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wannan Chen, MD

CONTACT

8613524684181; chen.wannan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: patients will be devided randomly into two groups. One group will be given oxycodone and the other will be given fentanyl during the POEM procedure. Post procedure pain condition will be recorded.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: November 26, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: November 26, 2019

Record last verified: 2019-11