Tokyo, June 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062063) titled 'Assessment of catheter displacement at the insertion site and bleeding status following the insertion of a catheter into the back for postoperative pain management' on June 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - National Hospital Organization Higashi-Ohmi General Medical Center
Condition:
Condition - Postoperative Pain That Can Be Managed with Epidural Analgesia at the Hospital Where the Researchers Are Affiliated
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Epidural catheters inserted via the back for postoperative analgesia are widely used for postoperative pain management. However, bleeding at the catheter insertion site and catheter migration may occur over time, potentially hindering the continuation of epidural analgesia.
This study aimed to assess the incidence of these complications during epidural catheterization, evaluate the impact of preventive measures, and compare the occurrence of these events before and after their implementation.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Application of biocompatible tissue adhesive to the insertion site following epidural catheter placement
Interventions/Control_2 - Creation of an approximately 2-cm subcutaneous tunnel following epidural catheter placement
Eligibility:
Age-lower limit - 16
years-old
Gender - Male and Female
Key inclusion criteria - Patients scheduled to undergo surgery for which postoperative analgesia with epidural analgesia is expected to be beneficial, who are classified as American Society of Anesthesiologists (ASA) Physical Status I or II, have no abnormalities in hemostatic or coagulation function, and have provided written informed consent to participate in this study before surgery.
Key exclusion criteria - Patients meeting any of the following criteria will be excluded:
1. Patients scheduled to undergo surgery for which postoperative analgesia with epidural analgesia is not expected to be beneficial.
2. Patients classified as American Society of Anesthesiologists (ASA) Physical Status III or higher.
3. Patients undergoing emergency surgery.
4. Patients with abnormalities in hemostatic or coagulation function.
5. Patients from whom written informed consent for participation in this study could not be obtained before surgery.
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 20 Day
Date of IRB - 2026 Year 05 Month 20 Day
Anticipated trial start date - 2026 Year 06 Month 30 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071015
Disclaimer: Curated by HT Syndication.
