Opioid Free Anesthesia: What About Patient Comfort?

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Other: OFA

• Registration Number: NCT02882035
• Lead Sponsor: Université Libre de Bruxelles

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-26
• Last Update Submitted: 2016-08-26
• Study First Posted: 2016-08-29
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFA (opioid free anesthesia)	OFA	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post-operative NRS	during 24 hours post-operative	Pain assessment via NRS
Post-operative piritramide consumption	during the first 24 hours post-operative

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium