Opioid Free Anesthesia in Breast Cancer Surgery

Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study

A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.

Study Overview

• Status: Completed
• Conditions: Opioid Free Anesthesia
• Intervention / Treatment: Procedure: paravertebral block; Drug: opioid free anesthesia; Procedure: sham block; Procedure: opioid general anesthesia

Detailed Description

Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.

The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
2. ASA physical statue I-II;

Exclusion Criteria:

1. chronic pain and opioid administration history;
2. allergy to local anesthetics or NSAIDs;
3. coagulation disorders;
4. local infection at regional block site;
5. unable to comply to study protocol schedule for logistic or other reasons;
6. refusal to participate to the study；
7. breast reconstruction with implants or latissimus dorsi flap

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: nerve block+opioid-free general anesthesia; Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia	Procedure: paravertebral block; Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site.; Other Names: nerve block; Drug: opioid free anesthesia; propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.; Other Names: opioid free
SHAM_COMPARATOR: sham bock+opioid general anesthesia; Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia	Procedure: sham block; Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.; Other Names: local infiltration; Procedure: opioid general anesthesia; propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .; Other Names: traditional general aneshesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of recovery	15-item 15-item 15-item quality of recovery questionnaire	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health related quality of life	evaluated using EuroQol 5 dimensions questionnaire	up to 3 months after surgery
postoperative pain	Numeric Rating Scale pain scores, pain questionnaires	up to 3 months after surgery
cancer recurrence and metastasis	diagnosed by breast cancer specialist	up to 12 months after surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Publications and helpful links

General Publications

• Tripathy S, Rath S, Agrawal S, Rao PB, Panda A, Mishra TS, Nayak S. Opioid-free anesthesia for breast cancer surgery: An observational study. J Anaesthesiol Clin Pharmacol. 2018 Jan-Mar;34(1):35-40. doi: 10.4103/joacp.JOACP_143_17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ACTUAL): March 15, 2022

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (ACTUAL): May 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: OFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No