Opioid Free Anesthesia in Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Free Anesthesia

Intervention / Treatment
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* Procedure: paravertebral block
* Drug: opioid free anesthesia
* Procedure: sham block
* Procedure: opioid general anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes; ASA physical statue I-II; Exclusion Criteria: chronic pain and opioid administration history; allergy to local anesthetics or NSAIDs; coagulation disorders; local infection at regional block site; unable to comply to study protocol schedule for logistic or other reasons; refusal to participate to the study； breast reconstruction with implants or latissimus dorsi flap

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nerve block+opioid-free general anesthesia<br>Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia | Procedure: paravertebral block<br>* 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.<br>* Other names: nerve block;Drug: opioid free anesthesia<br>* propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.<br>* Other names: opioid free;|
| Sham Comparator: sham bock+opioid general anesthesia<br>Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia | Procedure: sham block<br>* Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.<br>* Other names: local infiltration;Procedure: opioid general anesthesia<br>* propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .<br>* Other names: traditional general aneshesia;|

What is the study measuring?
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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 |