Opioid Free AnesthesiaNCT04390698
Opioid Free Anesthesia in Breast Cancer Surgery
A study testing paravertebral block, opioid free anesthesia and opioid general anesthesia in people with Opioid Free Anesthesia, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Opioid Free Anesthesia
- What is being tested?
- paravertebral block, opioid free anesthesia and opioid general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
- ASA physical statue I-II;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study
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.
Read the 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.
- Conditions
- Opioid Free Anesthesia
- Being tested
- paravertebral block, opioid free anesthesia, sham block, opioid general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
Also called nerve 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 anesthesiaDrug
Also called opioid free
propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.
sham blockProcedure or surgery
Also called local infiltration
Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.
opioid general anesthesiaProcedure or surgery
Also called traditional general aneshesia
propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .
| Study group | Role | What they receive |
|---|---|---|
| nerve block+opioid-free general anesthesia | Experimental | Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia Receives: Procedure: paravertebral block; Drug: 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 Receives: Procedure: sham block; Procedure: opioid general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery
15-item 15-item 15-item quality of recovery questionnaire
Measured: 24 hours after surgery
Secondary outcomes (3)
health related quality of life
evaluated using EuroQol 5 dimensions questionnaire
Measured: up to 3 months after surgery
postoperative pain
Numeric Rating Scale pain scores, pain questionnaires
Measured: up to 3 months after surgery
cancer recurrence and metastasis
diagnosed by breast cancer specialist
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Jul 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD,PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390698
- Sponsor's protocol ID
- OFA
- Status last verified
- Mar 2022
- First submitted
- 8 May 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29643620Zhang 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.
PubMed 37218631
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04390698
- Acronym / sponsor ID
- OFA
- Conditions
- Opioid Free Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nerve block+opioid-free general anesthesia | Experimental | Procedure: paravertebral block, Drug: opioid free anesthesiaParavertebral block with an ultrasound-guided technique; opioid-free general anesthesia |
| sham bock+opioid general anesthesia | Sham comparator | Procedure: sham block, Procedure: opioid general anesthesiaSham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
- ASA physical statue I-II;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paravertebral blockAlso: nerve blockParavertebral 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. | Procedure or surgery | nerve block+opioid-free general anesthesia |
| opioid free anesthesiaAlso: opioid freepropofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained. | Drug | nerve block+opioid-free general anesthesia |
| sham blockAlso: local infiltrationLocal infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site. | Procedure or surgery | sham bock+opioid general anesthesia |
| opioid general anesthesiaAlso: traditional general aneshesiapropofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained . | Procedure or surgery | sham bock+opioid general anesthesia |
Primary outcome
quality of recovery
Time frame: 24 hours after surgery
15-item 15-item 15-item quality of recovery questionnaire
3 secondary outcomes
health related quality of life
Time frame: up to 3 months after surgery
postoperative pain
Time frame: up to 3 months after surgery
cancer recurrence and metastasis
Time frame: up to 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Results publication: PubMed 29643620Tripathy 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.
- Derived from this study: PubMed 37218631Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Feng, MD,PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paravertebral block, opioid free anesthesia and opioid general anesthesia in people with Opioid Free Anesthesia, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of recovery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.