|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000026336 |
|
Date of registration:
|
01/03/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
|
|
Scientific title:
|
Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy - Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy |
|
Date of first enrolment:
|
2014/01/06 |
|
Target sample size:
|
96 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014902 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase II
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Noriyuki Matsutani |
|
Address:
|
2-11-1 Kaga, Itabashi-ku Tokyo, Japan
|
|
Telephone:
|
+81-3-3964-1231 |
|
Email:
|
matsutan@med.teikyo-u.ac.jp |
|
Affiliation:
|
Teikyo University School of Medicine Surgery |
|
|
Name:
|
Noriyuki Matsutani |
|
Address:
|
2-11-1 Kaga, Itabashi-ku Tokyo Japan
|
|
Telephone:
|
+81-3-3964-1231 |
|
Email:
|
matsutani1970@yahoo.co.jp |
|
Affiliation:
|
Teikyo University School of Medicine Surgery |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: patients who are taking antidepressants, anti-seizure drugs, and/or opioids prior to surgery patients with serious complications (such as uncontrollable heart, lung, liver or kidney disease, and diabetes) patients with a history of angioedema female patients who are pregnant, nursing, or might be pregnant (voluntary) patients who are problematic in receiving epidural anesthesia (such as patients with spinal deformity and patients undergoing treatment with anticoagulants) patients considered unsuitable for the study by a primary physician
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
patients undergoing thoracotomy requiring manipulation intercostals and ribs
|
|
Intervention(s)
|
Epidural anesthesia group -Initial medication on the day of surgery: Oral administration of 400mg of celecoxib -Medication 6 hours after administering initial dose: Oral administration of 200mg of celecoxib -During surgery: Pain control by epidural anesthesia with continuing administration of 0.2% ropivacaine hydrochloride and fentanyl for 48 hours after surgery -Medication one day after surgery: Oral administration of 200mg celecoxib 2T 2x (morning and evening)
Pregabalin group -Initial medication on the day of surgery: Oral administration of 400mg of celecoxib and 75mg of pregabalin -Medication 6 hours after administering initial dose: Oral administration of 200mg of celecoxib and 75mg of pregabalin -Medication one day after surgery: Oral administration of 200mg celecoxib 2T 2x (morning and evening) and 75mg of pregabalin 2T 2x (morning, evening)
|
|
Primary Outcome(s)
|
|
Pain score (NRS) on the first postoperative day (1 POD NRS)
|
|
Secondary Outcome(s)
|
|
Pain score (NRS) on the third and fifth postoperative day (3, 5 POD NRS) Frequency of analgesic drug use for pain control Sleep disorder score on the first, third, and fifth postoperative day Occurrence rate and severity of adverse effects Time periods of anesthesia in preparation for and during surgery
|
|
Source(s) of Monetary Support
|
|
Pfizer
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|