Opioid Free Anesthesia: What About Patient Comfort?

August 26, 2016 updated by: Sarah Saxena, Université Libre de Bruxelles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OFA (opioid free anesthesia)

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.
Other: OFA
No Intervention: OA (opioid anesthesia)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoR-40
Time Frame: 24 hours post-operatively
Patient comfort was assessed via the QoR-40 questionnaire 24hours post-operatively.
24 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative NRS
Time Frame: during 24 hours post-operative
Pain assessment via NRS
during 24 hours post-operative
Post-operative piritramide consumption
Time Frame: during the first 24 hours post-operative
during the first 24 hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Collaborators

Jules Bordet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE2261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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