Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2020-07-01
2022-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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nerve block+opioid-free general anesthesia
Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia
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.
opioid free anesthesia
propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.
sham bock+opioid general anesthesia
Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia
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 .
Interventions
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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.
opioid free anesthesia
propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.
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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ASA physical statue I-II;
Exclusion Criteria
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
20 Years
75 Years
FEMALE
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Yi Feng, MD
Chief of the Anesthesiology Department
Principal Investigators
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Yi Feng, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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.
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.
Other Identifiers
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OFA
Identifier Type: -
Identifier Source: org_study_id
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