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

NCT05831761 | Completed

• 1 other identifier: 151/03/09
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of different postoperative analgesia after laparoscopic colorectal surgery

Conditions

Postoperative Pain

Keywords

postoperative analgesia; neuropathic pain; laparoscopic colorectal surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

PCA

EXPERIMENTAL

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

PCEA

EXPERIMENTAL

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

tramadol

EXPERIMENTAL

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

lidocaine

EXPERIMENTAL

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

Interventions

Comparison of analgesic efficacy protocol DRUG

Comparison of 4 possible analgesic protocols

Also known as: PCA priritramide, PCEA, tramadole and metamizole, PCA and topical lidocaine

PCA; PCEA; lidocaine; tramadol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled elective laparoscopic colorectal surgery

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Related Publications (2)

• 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.

  PMID: 17197840 RESULT

• 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.

  PMID: 24030782 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia

Interventions

Dipyrone; Passive Cutaneous Anaphylaxis; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Matej Jenko

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomised by random number generator after meeting the inclusion criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asoc. prof.

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

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: April 26, 2023
• Study Start: September 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2013
• Last Updated: April 26, 2023

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share