Opioid Free Anesthesia
Conditions
Brief summary
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
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.
Interventions
PROCEDUREparavertebral 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.
DRUGopioid free anesthesia
propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.
PROCEDUREsham block
Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.
PROCEDUREopioid general anesthesia
propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of recovery | 24 hours after surgery | 15-item 15-item 15-item quality of recovery questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| health related quality of life | up to 3 months after surgery | evaluated using EuroQol 5 dimensions questionnaire |
| postoperative pain | up to 3 months after surgery | Numeric Rating Scale pain scores, pain questionnaires |
| cancer recurrence and metastasis | up to 12 months after surgery | diagnosed by breast cancer specialist |
Countries
China
Outcome results
None listed