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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04177342
Other study ID # POEM pain control
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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