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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Comparison of analgesic efficacy protocol
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative analgesia, neuropathic pain, laparoscopic colorectal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    PCA

    PCEA

    tramadol

    lidocaine

    Arm Description

    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)

    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).

    Continous postoperative infusion of tramadol 300 mg and metamizole 2,5 g (in 500 ml 0.9% NaCl, rate of infusion 40 ml/h)

    Postoperative topical lidocaine and PCA (piritramide 0.5 mg/ml; infusion 0.5 mg/h, bolus 1.5 mg, lock out 20 minutes)

    Outcomes

    Primary Outcome Measures

    Total opioid consumption
    Measurement of piritramide consumprion
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2021
    Last Updated
    April 25, 2023
    Sponsor
    University Medical Centre Ljubljana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05831761
    Brief Title
    Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
    Official Title
    Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2009 (Actual)
    Primary Completion Date
    October 1, 2011 (Actual)
    Study Completion Date
    October 1, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Centre Ljubljana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    postoperative analgesia, neuropathic pain, laparoscopic colorectal surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    4 parallel groups with different method of analgesia after laparoscopic colorectal resection.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Randomised by random number generator after meeting the inclusion criteria.
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCA
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    PCEA
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    tramadol
    Arm Type
    Experimental
    Arm Description
    Continous postoperative infusion of tramadol 300 mg and metamizole 2,5 g (in 500 ml 0.9% NaCl, rate of infusion 40 ml/h)
    Arm Title
    lidocaine
    Arm Type
    Experimental
    Arm Description
    Postoperative topical lidocaine and PCA (piritramide 0.5 mg/ml; infusion 0.5 mg/h, bolus 1.5 mg, lock out 20 minutes)
    Intervention Type
    Drug
    Intervention Name(s)
    Comparison of analgesic efficacy protocol
    Other Intervention Name(s)
    PCA priritramide, PCEA, tramadole and metamizole, PCA and topical lidocaine
    Intervention Description
    Comparison of 4 possible analgesic protocols
    Primary Outcome Measure Information:
    Title
    Total opioid consumption
    Description
    Measurement of piritramide consumprion
    Time Frame
    0-48 hours after surgical procedure
    Title
    Presence of neuropathic pain
    Description
    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.
    Time Frame
    first 3 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: scheduled elective laparoscopic colorectal surgery Exclusion Criteria: critical preoperative state, pregnant women, laparotomy and palliative procedures.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matej Jenko
    Organizational Affiliation
    University Medical Centre Ljubljana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17197840
    Citation
    Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
    Results Reference
    result
    PubMed Identifier
    24030782
    Citation
    Tikuisis R, Miliauskas P, Samalavicius NE, Zurauskas A, Samalavicius R, Zabulis V. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. Tech Coloproctol. 2014 Apr;18(4):373-80. doi: 10.1007/s10151-013-1065-0. Epub 2013 Sep 13.
    Results Reference
    result

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

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