Opioid Free Anesthesia in Breast Cancer Surgery

Not Applicable

Completed

• Conditions: Opioid Free Anesthesia
• Interventions: Procedure: paravertebral block; Procedure: sham block; Drug: opioid free anesthesia; Procedure: opioid general anesthesia

• Registration Number: NCT04390698
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Study Start: 2020-07-01
• Primary Completion: 2021-03-15
• Status Verified: 2022-03
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nerve block+opioid-free general anesthesia	paravertebral block	Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia
nerve block+opioid-free general anesthesia	opioid free anesthesia	Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia
sham bock+opioid general anesthesia	sham block	Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia
sham bock+opioid general anesthesia	opioid general anesthesia	Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia

Primary Outcome Measures

Name	Time	Method
quality of recovery	24 hours after surgery	15-item 15-item 15-item quality of recovery questionnaire

Secondary Outcome Measures

Name	Time	Method
health related quality of life	up to 3 months after surgery	evaluated using EuroQol 5 dimensions questionnaire
cancer recurrence and metastasis	up to 12 months after surgery	diagnosed by breast cancer specialist
postoperative pain	up to 3 months after surgery	Numeric Rating Scale pain scores, pain questionnaires

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China