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

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT05831761

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of different postoperative analgesia after laparoscopic colorectal surgery

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Comparison of analgesic efficacy protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

4 parallel groups with different method of analgesia after laparoscopic colorectal resection.4 parallel groups with different method of analgesia after laparoscopic colorectal resection.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Randomised by random number generator after meeting the inclusion criteria.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCA 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 Comparison of 4 possible analgesic protocols Other Names: PCA priritramide PCEA tramadole and metamizole PCA and topical lidocaine
Experimental: PCEA 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 Comparison of 4 possible analgesic protocols Other Names: PCA priritramide PCEA tramadole and metamizole PCA and topical lidocaine
Experimental: tramadol 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 Comparison of 4 possible analgesic protocols Other Names: PCA priritramide PCEA tramadole and metamizole PCA and topical lidocaine
Experimental: lidocaine 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 Comparison of 4 possible analgesic protocols Other Names: PCA priritramide PCEA tramadole and metamizole PCA and topical lidocaine

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

scheduled elective laparoscopic colorectal surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

Principal Investigator: Matej Jenko, University Medical Centre Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alenka Spindler-Vesel, asoc. prof., University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT05831761

Other Study ID Numbers:

151/03/09

First Posted:

Apr 26, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alenka Spindler-Vesel, asoc. prof., University Medical Centre Ljubljana

postoperative analgesia

neuropathic pain

laparoscopic colorectal surgery

Additional relevant MeSH terms:

Pain, Postoperative

Lidocaine

Analgesics

Study Results

No Results Posted as of Apr 26, 2023