Opioid Free Anesthesia in Breast Cancer Surgery

Peking University

Status: Completed

Conditions: Opioid Free Anesthesia

Treatments: Procedure: sham block; Procedure: paravertebral block; Drug: opioid free anesthesia; Procedure: opioid general anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04390698

OFA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

nerve block+opioid-free general anesthesia

Experimental group

Description:

Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia

Treatment:

Drug: opioid free anesthesia

Procedure: paravertebral block

sham bock+opioid general anesthesia

Sham Comparator group

Description:

Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia

Treatment:

Procedure: opioid general anesthesia

Procedure: sham block