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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02882035
Other study ID # CE2261
Secondary ID
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


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
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