OFA - Opioid Free Anesthesia

Ketamine

Brief Summary

Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH). OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.

Intervention / Treatment

randomized double blind trial
  • Remifentanil (DRUG)
    continuous infusion intraop
  • Ketamine (DRUG)
    bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
  • Lidocaine (DRUG)
    lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
  • Clonidine (DRUG)
    clonidine 4 mcg/kg

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 90 Years
    Enrollment: 64 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 04, 2017 ACTUAL
    Primary Completion: Dec 31, 2017 ESTIMATED
    Completion Date: Mar 31, 2018 ESTIMATED
    Study First Posted: Apr 21, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 18, 2017

    Sponsors / Collaborators

    Lead Sponsor: University of Parma
    Responsible Party: N/A

    Location

    Parma, Emilia-Romagna, Italy

    Participant Groups

    • remifentanil 0,15-0,25 mcg/kg/h

    • ketamine bolus 0,5 mg/kg + infusion 0,25 mg/kg/h lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h clonidine 4 mcg/kg

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 90
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * left hemicolectomy
    * signed informed consent
    * \>18 ys

    Exclusion Criteria:

    * \>90 ys \<18 ys
    * no consent
    * pregnancy
    * psychiatric disease
    * cardiac failure, aortic or mitral valve severe stenosis
    * kidney or hepatic failure
    * atrio-ventricular type II block
    * immunodepression
    * emergency surgery
    * ICU admittance
    * drug or alcohol abuse
    * chronic pain

    Primary Outcomes

    • morphine mg by PCA (Patient Controlled Analgesia)

    Secondary Outcomes

    • nausea and vomiting, ileus, itching, shiver, hypotension, bradycardia, sedation

    • VAS (Visual Analog Scale)

    • assessment of primary hyperalgesia by Von Frey Filaments at 24 hours

    • assessment of secondary hyperalgesia by pin-prick test at 24 hours

    More Details

    NCT Number: NCT03124082
    Acronym: OFA
    Other IDs: 34477
    Study URL: https://clinicaltrials.gov/study/NCT03124082
    Last updated: Sep 29, 2023