Evaluation of the effect of continuous peri-scar infiltration of local anesthetic on the area of ​​secondary hyperalgesia related to the surgical specimen extraction scar after laparoscopic colectomy (CatCH Study) - CATCH

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Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: NAROPEINE Product Name: NAROPEINE Pharmaceutical Form: Solution for injection INN or Proposed INN: Naropeine Other descriptive name: Ropivocaine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2mg/ml‐ Trade Name: Xylocaine Product Name: Xylocaine Pharmaceutical Form: Solution for injection INN or Proposed INN: Xylocaine CAS Number: 137‐58‐6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5 mg/ml‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Extraction of surgical specimen after laparoscopic colectomy; MedDRA version: 8.1 Level: PT Classification code 10056350 Term: Requiring abdominal surgery INCLUSION CRITERIA: Criteria assessed on the day before the procedure - Patients aged 18 to 80 years - American Society of Anesthesiologists (ASA) classification I to III - Laparoscopic colorectal surgery - Satisfactory level of French comprehension and expression - Signed informed consent after information provided by the investigator - Affiliation with a social security plan (beneficiary or dependent). Are the trial subjects under 18? No. Number of subjects for this age range: F.1.2 Adults (18–64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range PRIMARY OUTCOME: Main Objective: To compare continuous peri-scar infiltration of ropivocaine (for 48 hours) using a Painfusor multi-perforated catheter and its placebo on the surface area of ​​secondary hyperalgesia measured 72 hours after treatment initiation, taking into account the potential effect of systemic absorption of local anesthetics. Primary endpoint(s): Main endpoint; Mean ratio of secondary hyperalgesia surface area (in cm²) / scar length (in cm). Area of ​​the hyperalgesic zone measured using von Frey filaments and expressed as the ratio [area of ​​the peri-scar hyperalgesic zone (cm2) / scar length (cm)]; The primary endpoint will be assessed on day 3 (H+72), by one of the center's investigators, blinded to the administered treatment.; Secondary endpoints: - Total morphine consumption (mg) (at H+24 and H+48); - Analgesic effect: visual analog scale; - Ratio of hyperalgesic area (in cm2) / scar length (in cm) (at H+120); - Influence of intravenous lidocaine administration on postoperative secondary hyperalgesia; - Average ratio of the area of ​​hyperalgesia (in cm2) / scar length (in cm) between the INFILTRATION group (ropivocaine) and the IV group (Lidocaine); - Effect on protein hypercatabolism: measurement of adrenaline, noradrenaline, glucagon, insulin, glucose, cortisol, and plasma ACTH (on day 0: anesthetic induction, T0: start of continuous infiltration, H+8, H+24, H+48); - Effect on the inflammatory response: measurement of CRP (C-Reactive Protein) on day 0, T0, H+8, H+24, H+48. Secondary Objective: Effect of continuous peri-scar infiltration on: - postoperative pain at rest and during mobilization; - Postoperative morphine consumption (patient-controlled administration); - The occurrence of any persistent pain, assessed 3 to 6 months after the procedure; - The effects of pericicatricial infiltration and intravenous lidocaine on the area of ​​secondary hyperalgesia measured 72 hours after treatment initiation; - The postoperative inflammatory response; - The postoperative endocrine and metabolic response
Epistemonikos ID: 40022eeab4367870053a15e67f84e559fef62cd3
First added on: Aug 22, 2024
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