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OpenTrials
Completed

NCT Number: NCT02882035

Opioid Free Anesthesia: What About Patient Comfort?

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.

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Institut Jules Bordet

Brussels, Brussels Capital, 1000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OFA

Other

Primary outcomes

  1. QoR-40

    Time frame: 24 hours post-operatively

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

Secondary outcomes

  1. Post-operative NRS

    Time frame: during 24 hours post-operative

    Pain assessment via NRS

  2. Post-operative piritramide consumption

    Time frame: during the first 24 hours post-operative

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Collaborators

  • Jules Bordet Institute

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 29, 2016
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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