Post Operative Pain Control of POEM Procedure

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04177342
• Other study ID #: POEM pain control
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Wannan Chen, MD
• Phone: 8613524684181
• Email: chen.wannan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia
• Pain, Postoperative

Intervention

Drug:
• Fentanyl
the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
• Oxycodone
the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chen Wannan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative pain condition	use Visual Analogue Scale/Score(0-10) to record post operative pain	36 hours after the POEM surgery
Primary	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
Primary	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	chronic pain condition	use Visual Analogue Scale/Score(0-10) to evaluate the pain condition	28 days after discharge