Post Operative Pain Control of POEM Procedure

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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