Opioid Free Anesthesia in Breast Cancer Surgery

Peking University People's Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Opioid Free Anesthesia

Interventions

paravertebral blockPROCEDURE

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.

opioid free anesthesiaDRUG

propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.

sham blockPROCEDURE

Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

quality of recovery

15-item 15-item 15-item quality of recovery questionnaire

Time frame: 24 hours after surgery

Secondary Outcomes

health related quality of life

evaluated using EuroQol 5 dimensions questionnaire

Time frame: up to 3 months after surgery

postoperative pain

Numeric Rating Scale pain scores, pain questionnaires

Time frame: up to 3 months after surgery

cancer recurrence and metastasis

diagnosed by breast cancer specialist

Time frame: up to 12 months after surgery

Data from ClinicalTrials.gov

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