Opioid Free Anesthesia: What About Patient Comfort?

Ketamine

Brief Summary

66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.

Intervention / Treatment

  • OFA (OTHER)
    N/A

Condition or Disease

  • Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: Child, Adult, Older Adult
    Enrollment: 66 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2014
    Primary Completion: Jul 01, 2015 ACTUAL
    Completion Date: Jul 01, 2015 ACTUAL
    Study First Posted: Aug 29, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 26, 2016

    Sponsors / Collaborators

    Lead Sponsor: Université Libre de Bruxelles
    Responsible Party: N/A

    Location

    Brussels, Belgium

    Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.

    The purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.

    The hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.

    Participant Groups

    • All drugs were given IV. Induction in the opioid free group began with a loading dose of clonidine (0.2 mcg kg-1), a bolus of ketamine (0.3 mg kg -1) lidocaine (1.5 mg kg -1) and a bolus of propofol (2-3 mg kg -1). General anesthesia was maintained with sevoflurane (MAC: 1) (adapted according to hemodynamic stability). Upon the incision, acetaminophen (1000 mg) and diclofenac (75 mg) were given in both groups. A bolus of ketamine (0.2mg kg -1) was given if necessary in the opioid free group (up to three bolus max. were permitted). A bolus of piritramide (0.03 mg kg -1) was administered upon subcutaneous closure. Postoperative pain was treated with IV acetaminophen (1000 mg) every 6 h for the first 24 hours and IV diclofenac (75 mg) every 12 h for the first 24 hours. Patients received a PCIA (patient-controlled intravenous analgesia) pump of piritramide.

    • All drugs were given IV. Induction in the opioid group began with remifentanil TCI, a bolus of ketamine (0.3 mg kg -1) lidocaine (1.5 mg kg -1) and a bolus of propofol (2-3 mg kg -1). General anesthesia was maintained with sevoflurane (MAC: 1). Upon the incision, acetaminophen (1000 mg) and diclofenac (75 mg) were given in both groups. A bolus of piritramide (0.03 mg kg -1) was administered upon subcutaneous closure. Postoperative pain was treated with IV acetaminophen (1000 mg) every 6 h for the first 24 hours and IV diclofenac (75 mg) every 12 h for the first 24 hours. Patients received a PCIA (patient-controlled intravenous analgesia) pump of piritramide.

    Eligibility Criteria

    Sex: Female
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Oncological patients undergoing a total mastectomy or lumpectomy associated with a total axillary dissection were screened.
    * Patients with an ASA physical status of II were included.
    * Knowledge of either French, English or Dutch was required.

    Exclusion criteria were the following:

    * Allergy or contraindications to one of the study drugs, renal failure, hepatic failure, hyperthyroidism, AV block 2 or 3 or severe bradycardia, left ventricular failure, unstable blood pressure, epilepsy and psychiatric disturbance.

    Primary Outcomes

    • Patient comfort was assessed via the QoR-40 questionnaire 24hours post-operatively.

    Secondary Outcomes

    • Pain assessment via NRS

    • Post-operative piritramide consumption during the first 24 hours post-operative

    More Details

    NCT Number: NCT02882035
    Other IDs: CE2261
    Study URL: https://clinicaltrials.gov/study/NCT02882035
    Last updated: Sep 29, 2023