Opioid Free Anesthesia: What About Patient Comfort?

NCT02882035 | Completed Phase 4

• 1 other identifier: CE2261
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

pain; patient comfort

Outcome Measures

Primary Outcomes (1)

• QoR-40

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

  24 hours post-operatively

Secondary Outcomes (2)

• Post-operative NRS

  during 24 hours post-operative

• Post-operative piritramide consumption

  during the first 24 hours post-operative

Study Arms (2)

OFA (opioid free anesthesia)

EXPERIMENTAL

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

OA (opioid anesthesia)

NO INTERVENTION

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.

Interventions

OFA OTHER

OFA (opioid free anesthesia)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Libre de Bruxelles: lead
• Jules Bordet Institute: collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, Brussels Capital, 1000, Belgium

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

BE (1)