Post Operative Pain Control of POEM Procedure

Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04177342

Enrollment

196

Registered

2019-11-26

Start date

2020-01-01

Completion date

2021-06-30

Last updated

2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia

Keywords

achalasia, Peroral endoscopic myotomy, post-operative pain

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.

Interventions

DRUGFentanyl

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

DRUGOxycodone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
post-operative pain condition	36 hours after the POEM surgery	use Visual Analogue Scale/Score(0-10) to record post operative pain
post-operative PCA usage volumn	36 hours after the POEM surgery	record PCA usage volumn(ml) to see the dosage of opiods used after the surgery
post-operative sleep quality	48 hoursafter the surgery	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

Secondary

Measure	Time frame	Description
chronic pain condition	28 days after discharge	use Visual Analogue Scale/Score(0-10) to evaluate the pain condition

Contacts

Primary ContactWannan Chen, MD

chen.wannan@zs-hospital.sh.cn8613524684181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026