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

Study Overview
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Brief Summary
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Comparison of different postoperative analgesia after laparoscopic colorectal surgery

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Comparison of analgesic efficacy protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled elective laparoscopic colorectal surgery Exclusion Criteria: critical preoperative state, pregnant women, laparotomy and palliative procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 parallel groups with different method of analgesia after laparoscopic colorectal resection.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCA<br>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) | Drug: Comparison of analgesic efficacy protocol<br>* Comparison of 4 possible analgesic protocols<br>* Other names: PCA and topical lidocaine;|
| Experimental: PCEA<br>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). | Drug: Comparison of analgesic efficacy protocol<br>* Comparison of 4 possible analgesic protocols<br>* Other names: PCA and topical lidocaine;|
| Experimental: tramadol<br>Continous postoperative infusion of tramadol 300 mg and metamizole 2,5 g (in 500 ml 0.9% NaCl, rate of infusion 40 ml/h) | Drug: Comparison of analgesic efficacy protocol<br>* Comparison of 4 possible analgesic protocols<br>* Other names: PCA and topical lidocaine;|
| Experimental: lidocaine<br>Postoperative topical lidocaine and PCA (piritramide 0.5 mg/ml; infusion 0.5 mg/h, bolus 1.5 mg, lock out 20 minutes) | Drug: Comparison of analgesic efficacy protocol<br>* Comparison of 4 possible analgesic protocols<br>* Other names: PCA and topical lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption | Measurement of piritramide consumprion | 0-48 hours after surgical procedure | 
| Presence of neuropathic pain | 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. | first 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative analgesia, neuropathic pain, laparoscopic colorectal surgery