AnesthesiaPhase 4NCT02691195
Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy
A Phase 4 study testing Ropivacaine and 0.9% Nacl in people with Anesthesia, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
Regional anesthesia improves quality of recovery after surgery in many studies. Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative to current regional anesthetic techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ropivacaine and 0.9% Nacl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2016to 14 Jun 2017
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of American Society of Anesthesiologists' (ASA) Physical Status class I-II scheduled for first modified radical mastectomy were included.
Who cannot join
- Patients with chronic ethanol
- long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant);
- contraindications for serratus plane block including coagulopathy, infection at the puncture site;
- unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up;
- administration of other test drugs or joining in other clinical study in 3 months before our study;
- received radiotherapy or chemotherapy before surgery;
- other conditions not allocated for this study out of the researchers' consideration.
Trial locations and contacts
1 site in 1 country.
About this study
Regional anesthesia improves quality of recovery after surgery in many studies. Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative to current regional anesthetic techniques. This randomized, controlled trial is to examine the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast tumor resection.
Read the detailed description
A total of 72 subjects (36 patients for each groups) were enrolled in this study. Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) using randomized central computer-generated sequence software (SAS 19.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops. The major research content is to evaluate the quality of recovery using 40 questionnaire (QoR-40).
- Conditions
- Anesthesia
- Being tested
- Ropivacaine, 0.9% Nacl
- Keywords
- Ultrasound, Serratus Plane Block, Quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called local anesthetic
patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.
0.9% NaclDrug
Also called Normal saline
patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.
| Study group | Role | What they receive |
|---|---|---|
| group control | Placebo comparator | group control :Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg. Receives: Drug: 0.9% Nacl |
| group SPB | Experimental | group SPB:Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of recovery
The primary outcome was the quality of recovery, which was assessed at 24 hours after surgery using a 40-item questionnaire (QoR-40).
Measured: at 24 hours after surgery
Secondary outcomes (1)
Postoperative pain intensity
Postoperative pain intensity was rated at postoperative hours 0.5, 1, 2, 4, 8 and 24 with Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable.
Measured: at postoperative hours 0.5, 1, 2, 4, 8 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study start15 Mar 2016
- Primary completion12 Jun 2017
- Study completion14 Jun 2017
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 AnesthesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Yusheng Yao, PHD & MD, Principal investigator, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691195
- Sponsor's protocol ID
- K2016-1-07
- Status last verified
- Mar 2018
- First submitted
- 15 Feb 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.
PubMed 31021882
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT02691195
- Acronym / sponsor ID
- K2016-1-07
- Conditions
- Anesthesia
- Keywords
- Ultrasound, Serratus Plane Block, Quality of recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 25 Feb 2016 (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.
Regional anesthesia improves quality of recovery after surgery in many studies. Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative to current regional anesthetic techniques. This randomized, controlled trial is to examine the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast tumor resection.
Detailed description
A total of 72 subjects (36 patients for each groups) were enrolled in this study. Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) using randomized central computer-generated sequence software (SAS 19.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops. The major research content is to evaluate the quality of recovery using 40 questionnaire (QoR-40).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group control | Placebo comparator | Drug: 0.9% Naclgroup control :Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg. |
| group SPB | Experimental | Drug: Ropivacainegroup SPB:Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of American Society of Anesthesiologists' (ASA) Physical Status class I-II scheduled for first modified radical mastectomy were included.
Key exclusion criteria (7 listed)
- Patients with chronic ethanol
- long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant);
- contraindications for serratus plane block including coagulopathy, infection at the puncture site;
- unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up;
- administration of other test drugs or joining in other clinical study in 3 months before our study;
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 |
|---|---|---|
| RopivacaineAlso: local anestheticpatients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg. | Drug | group SPB |
| 0.9% NaclAlso: Normal salinepatients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg. | Drug | group control |
Primary outcome
The quality of recovery
Time frame: at 24 hours after surgery
The primary outcome was the quality of recovery, which was assessed at 24 hours after surgery using a 40-item questionnaire (QoR-40).
1 secondary outcome
Postoperative pain intensity
Time frame: at postoperative hours 0.5, 1, 2, 4, 8 and 24
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 6 Mar 2018.
- Background: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Derived from this study: PubMed 31021882Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.
- 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.
Yusheng Yao, PHD & MD principal investigator
Fujian Provincial Hospital
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 Ropivacaine and 0.9% Nacl in people with Anesthesia, run by Fujian Provincial 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 1 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 6 Mar 2018. 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.
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?
The quality of recovery (time frame: at 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 NCT02691195, 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 6 Mar 2018.