Opioid Free Anesthesia in Breast Cancer Surgery

Opioid Free Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390698
• Other study ID #: OFA
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Free Anesthesia

Intervention

Procedure:
• paravertebral 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.

Drug:
• opioid free anesthesia
propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.

Procedure:
• sham block
Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.
• opioid general anesthesia
propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of recovery	15-item 15-item 15-item quality of recovery questionnaire	24 hours after surgery
Secondary	health related quality of life	evaluated using EuroQol 5 dimensions questionnaire	up to 3 months after surgery
Secondary	postoperative pain	Numeric Rating Scale pain scores, pain questionnaires	up to 3 months after surgery
Secondary	cancer recurrence and metastasis	diagnosed by breast cancer specialist	up to 12 months after surgery