Post Operative Pain Control of POEM Procedure

C

Chen Wannan

Status and phase

Unknown
Phase 4

Conditions

Achalasia

Treatments

Drug: Oxycodone
Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT04177342
POEM pain control

Details and patient eligibility

About

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.

Enrollment

196 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

196 participants in 2 patient groups

fentanyl
Active Comparator group
Description:
the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
Treatment:
Drug: Fentanyl
oxycodone
Experimental group
Description:
the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
Treatment:
Drug: Oxycodone

Trial contacts and locations

0

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Central trial contact

Wannan Chen, MD

Data sourced from clinicaltrials.gov

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