Viewing Study NCT05831761


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Study NCT ID: NCT05831761
Status: COMPLETED
Last Update Posted: 2023-04-26
First Post: 2021-01-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
Sponsor: University Medical Centre Ljubljana
Organization:

Study Overview

Official Title: Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
Status: COMPLETED
Status Verified Date: 2021-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Comparison of different postoperative analgesia after laparoscopic colorectal surgery
Detailed Description: Postoperative pain treatment should be multimodal and opioid sparing. Thoracic epidural analgesia could relieve pain after laparoscopic surgery. Although ERAS guidelines suggest to use less invasive pain relieve technique, opioids are widely used perioperatively, despite of their side effects. Non-opioids and 5% lidocaine patches, used topicaly, could effectively reduce opioid consumption and their side effects.

Namely, efficient perioperative pain treatment is important to prevent late neuropathic pain, also after laparoscopic lower abdominal surgery. Its incidence is usually low compared to open surgery.

The aim of present study was to evaluate, if opioid consumption in laparoscopic colorectal surgery could be reduced with lidocaine patch at the wound site or with infusion of metamizole and tramadol and if the results meets epidural analgesia. We also compared the incidence of postoperative neuropathic pain among groups.

Prospective, randomised trial with 4 parallel groups was conducted at the University medical centre (UMC) Ljubljana. ASA (American Society of Anaesthesiologists) Class 2-3 high risk surgical patients from the Clinical department of abdominal surgery were included in the study. Adult patients that underwent laparoscopic colorectal surgery were included.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: