Opioid Free Anesthesia: What About Patient Comfort?

Anesthesia Clinical Trial

Official title:

Opioid Free Anesthesia: What About Patient Comfort?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882035
• Other study ID #: CE2261
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2016
• Last updated: August 26, 2016
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• OFA

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Libre de Bruxelles	Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR-40	Patient comfort was assessed via the QoR-40 questionnaire 24hours post-operatively.	24 hours post-operatively	No
Secondary	Post-operative NRS	Pain assessment via NRS	during 24 hours post-operative	No
Secondary	Post-operative piritramide consumption		during the first 24 hours post-operative	No