NCT04390698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

May 8, 2020

Last Update Submit

March 24, 2022

Conditions

Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (1)

  • quality of recovery

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

    24 hours after surgery

Secondary Outcomes (3)

  • health related quality of life

    up to 3 months after surgery

  • postoperative pain

    up to 3 months after surgery

  • cancer recurrence and metastasis

    up to 12 months after surgery

Study Arms (2)

nerve block+opioid-free general anesthesia

EXPERIMENTAL

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

Procedure: paravertebral blockDrug: opioid free anesthesia

sham bock+opioid general anesthesia

SHAM COMPARATOR

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

Procedure: sham blockProcedure: opioid general anesthesia

Interventions

paravertebral blockPROCEDURE

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.

Also known as: nerve block
nerve block+opioid-free general anesthesia
opioid free anesthesiaDRUG

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

Also known as: opioid free
nerve block+opioid-free general anesthesia
sham blockPROCEDURE

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

Also known as: local infiltration
sham bock+opioid general anesthesia
opioid general anesthesiaPROCEDURE

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

Also known as: traditional general aneshesia
sham bock+opioid general anesthesia

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (2)

  • 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.

    PMID: 29643620RESULT

  • 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.

    PMID: 37218631DERIVED

MeSH Terms

Interventions

Nerve BlockAnesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yi Feng, MD,PhD

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Anesthesiology Department

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 15, 2020

Study Start

July 1, 2020

Primary Completion

March 15, 2021

Study Completion

March 15, 2022

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)