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Completed

NCT Number: NCT04390698

Opioid Free Anesthesia in Breast Cancer Surgery

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.

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Key information

Conditions

Opioid Free Anesthesia

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
  • ASA physical statue I-II;

Exclusion criteria

  • chronic pain and opioid administration history;
  • allergy to local anesthetics or NSAIDs;
  • coagulation disorders;
  • local infection at regional block site;
  • unable to comply to study protocol schedule for logistic or other reasons;
  • refusal to participate to the study；
  • breast reconstruction with implants or latissimus dorsi flap

Treatment and study plan

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.

Other names: nerve block

opioid free anesthesia

Drug

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

Other names: opioid free

Sham Block

Procedure

Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.

Other names: local infiltration

opioid general anesthesia

Procedure

propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .

Other names: traditional general aneshesia

Primary outcomes

  1. quality of recovery

    Time frame: 24 hours after surgery

    15-item 15-item 15-item quality of recovery questionnaire

Secondary outcomes

  1. health related quality of life

    Time frame: up to 3 months after surgery

    evaluated using EuroQol 5 dimensions questionnaire

  2. postoperative pain

    Time frame: up to 3 months after surgery

    Numeric Rating Scale pain scores, pain questionnaires

  3. cancer recurrence and metastasis

    Time frame: up to 12 months after surgery

    diagnosed by breast cancer specialist

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 15, 2020
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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