Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Comparison of analgesic efficacy protocol

• Registration Number: NCT05831761
• Lead Sponsor: University Medical Centre Ljubljana

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 Timeline

• Study Start: 2009-09-01
• Primary Completion: 2011-10-01
• Study Completion: 2013-10-01
• Study First Submitted: 2021-01-20
• Status Verified: 2021-03
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• scheduled elective laparoscopic colorectal surgery

Exclusion Criteria

• critical preoperative state, pregnant women, laparotomy and palliative procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCA	Comparison of analgesic efficacy protocol	Postoperative intravenous infusion of piritramid patient controlled analgesia (PCA) (piritramide 0.5 mg/ml; infusion 1,5 mg/h, bolus 1,5 mg, lock out 30 minutes)
PCEA	Comparison of analgesic efficacy protocol	Postoperative patient controlled epidural analgesia (epidural cathterer inserted into Th7-8 intervertebral space, 200 ml of 0.125% levobupivacaine, 4 mg of morphine, 0.075 mg of clonidine; infusion 5 ml/h, bolus 5 ml, lock out 30 minutes).
tramadol	Comparison of analgesic efficacy protocol	Continous postoperative infusion of tramadol 300 mg and metamizole 2,5 g (in 500 ml 0.9% NaCl, rate of infusion 40 ml/h)
lidocaine	Comparison of analgesic efficacy protocol	Postoperative topical lidocaine and PCA (piritramide 0.5 mg/ml; infusion 0.5 mg/h, bolus 1.5 mg, lock out 20 minutes)

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	0-48 hours after surgical procedure	Measurement of piritramide consumprion
Presence of neuropathic pain	first 3 months after surgery	Detecting of neuropathic pain using DN4 and PainDetect Questionnaire. These are clinically validated tools for detecting the presence of neuropathic pain and evaluating the severity.