Postoperative PainPhase 4PQSATNCT01499836
Quality Study of Anesthetic Technique on Breast Cancer Surgery
A Phase 4 study testing PVB in people with Postoperative Pain and Quality of Recovery, run by Nai Liang Li at 1 site in Taiwan.
Trial summary
Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain, Quality of Recovery, Satisfaction
- What is being tested?
- PVB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 4
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a physical status between ASA I and III
- Female
- 18 - 70 years of age
- Patients able to read a newspaper in Chinese.
- Elective unilateral wide excision/simple mastectomy and SLNB/ALND
- Patient has signed an informed consent
- Without contraindication of GA or PVB
- Body mass index (BMI) less than 24 kg/m2
Who cannot join
- ASA > III
- inability to provide informed consent
- Bleeding disorders
- Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
- Allergy to amide-type local anesthetics or NSAIDs
- Infection at the thoracic paravertebral injection site
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- Pregnancy or breast-feeding
- Severe spine or chest wall deformity
- body mass index equal to or more than 24 kg/m2
- patients with major psychosis or drug and alcohol abuse
- patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
- Patients with significant visual impairment or other physical disability that precludes complete cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery
Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.
- Conditions
- Postoperative Pain, Quality of Recovery, Satisfaction
- Being tested
- PVB
- Medical subject headings
- Pain, Postoperative, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVBOther
paravertebral block
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia and PVB | Experimental | general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. After intubation, paravertebral injections will be performed under ultrasound guidance. Receives: Other: PVB |
| sedation and PVB | Experimental | After sedation with midazolam and fentanyl, the patients in sedation and PVB group will receive PVB. paravertebral injections will be performed under ultrasound guidance.Intraoperative sedation will be provided with propofol titrated to moderate sedation. Receives: Other: PVB |
| general anesthesia | Active comparator | general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. Receives: Other: PVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery
Measured: postoperative 6 hour and postoperative day(POD)1
Secondary outcomes (4)
adverse events
Measured: POD1
Number of patients with a technique failure of the PVB
Measured: during operation
NRS pain score
Measured: postoperative 1 hour, 6 hour, and POD1
Satisfaction
Measured: POD1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nai Liang Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nai Liang Li, Sun Yat-sen University
- Investigators
- Nai Liang Li, Principal investigator, Koo Foundation Sun Yat-Sen Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499836
- Sponsor's protocol ID
- 20110920A
- Acronym
- PQSAT
- Status last verified
- Jan 2014
- First submitted
- 10 Dec 2011
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery
- ClinicalTrials.gov ID
- NCT01499836
- Acronym / sponsor ID
- PQSAT / 20110920A
- Conditions
- Postoperative Pain, Quality of Recovery, Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Nai Liang LiUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Dec 2011 (estimated)
- 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.
Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general anesthesia and PVB | Experimental | Other: PVBgeneral anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. After intubation, paravertebral injections will be performed under ultrasound guidance. |
| sedation and PVB | Experimental | Other: PVBAfter sedation with midazolam and fentanyl, the patients in sedation and PVB group will receive PVB. paravertebral injections will be performed under ultrasound guidance.Intraoperative sedation will be provided with propofol titrated to moderate sedation. |
| general anesthesia | Active comparator | Other: PVBgeneral anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has a physical status between ASA I and III
- Female
- 18 - 70 years of age
- Patients able to read a newspaper in Chinese.
- Elective unilateral wide excision/simple mastectomy and SLNB/ALND
Key exclusion criteria (12 listed)
- ASA > III
- inability to provide informed consent
- Bleeding disorders
- Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
- Allergy to amide-type local anesthetics or NSAIDs
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 |
|---|---|---|
| PVBparavertebral block | Other | general anesthesia, general anesthesia and PVB, sedation and PVB |
Primary outcome
quality of recovery
Time frame: postoperative 6 hour and postoperative day(POD)1
4 secondary outcomes
adverse events
Time frame: POD1
Number of patients with a technique failure of the PVB
Time frame: during operation
NRS pain score
Time frame: postoperative 1 hour, 6 hour, and POD1
Satisfaction
Time frame: POD1
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 16 Jan 2014.
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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.
Nai Liang Li principal investigator
Koo Foundation Sun Yat-Sen Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PVB in people with Postoperative Pain and Quality of Recovery, run by Nai Liang Li at 1 site in Taiwan.
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 8 inclusion and 12 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 16 Jan 2014. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: postoperative 6 hour and postoperative day(POD)1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2014.