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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nerve block+opioid-free general anesthesia | Experimental | Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia |
|
| sham bock+opioid general anesthesia | Sham Comparator | Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paravertebral block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| quality of recovery | 15-item 15-item 15-item quality of recovery questionnaire | 24 hours after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Feng, MD,PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29643620 | Result | 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. | |
| 37218631 | Derived | Zhang Q, Wu Y, An H, Feng Y. Postoperative recovery after breast cancer surgery: A randomised controlled trial of opioid-based versus opioid-free anaesthesia with thoracic paravertebral block. Eur J Anaesthesiol. 2023 Aug 1;40(8):552-559. doi: 10.1097/EJA.0000000000001856. Epub 2023 May 23. |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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|
| opioid free anesthesia | Drug | propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained. |
|
|
| sham block | Procedure | Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site. |
|
|
| opioid general anesthesia | Procedure | propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained . |
|
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| up to 3 months after surgery |
| cancer recurrence and metastasis | diagnosed by breast cancer specialist | up to 12 months after surgery |
| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |