SurgeryPhase 4NCT02905149
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
A Phase 4 study testing Serrato in people with Surgery and Breast Reconstruction, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Breast Reconstruction
- What is being tested?
- Serrato
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2016to 8 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years, undergoing oncological surgery and/or breast reconstruction surgery whose pathology and surgical intervention supose at least a 24 hours hospital admission
Who cannot join
- ASA Physical Status Classification System- IV.- Morbid obesity (Body mass index >40). -Impossibility of anatomical structures ultrasound identification in a satisfactory way (there can be no distinction in the interfascial plane between serratus and pectoral muscle). -Opioids treatment before surgery. Sepsis and/or infection at the puncture site.
- Haemostasis disorders. - Allergy to any of the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on postoperative analgesia.
Read the detailed description
Regional analgesia techniques have shown to have benefits over conventional analgesia. The lower opioids analgesics requirements decrease side effects associated with the use of this type of medication. It is also increasingly established scientific evidence that reducing opioids administration may play a role in prognosis of cancer patients given the immunosuppressive effect of these drugs.
In patients undergoing oncologic/reconstructive breast surgery paravertebral block has been traditionally performed, however the paravertebral space lacks a clear anatomical barrier from the spinal cord so the drugs administered can diffuse to the intervertebral foramen causing deeper levels of blocks (epidural or spinal blocks) and injections at the paravertebral level are associated with serious complications both neurological and respiratory (meningitis, spinal hematomas abscesses, pneumothorax, respiratory failure. This has led to the development of less invasive technique with an improved safety profile.
The serratus plane block falls within the framework of these newly developed techniques and the present study aims to assess its role in the management of the patient undergoing cancer / reconstructive surgery.
Considering a decrease in postoperative morphine consumption of 40% and the average consumption of opioid after breast surgery under general anesthesia is 15 milligrams ( standard deviation 8 mg ) investigators calculated that with an alpha error 5% power 80 % 56 patients (28 per group) were required to achieve a significant result. In anticipation of possible loss of sample, 60 patients were recruited . Analysis will be performed by intention to treat.
Quantitative variables (opioid consumption, pain estimated by VAS scale) will be analyzed using mixed linear model adding a random variable for interindividual variability for pain threshold. If the data do not meet the criteria of normality the Mann-Whitney U test will be used. If the groups differ in preoperative variables. Investigators will make a multivariable analysis adjusting for these variables. The need for rescue analgesia over time is analyzed by Kaplan-Meier curve where the terminal state is the administration of the first dose of opioid postoperatively. The difference side effects (nausea, pruritus, apnea, urinary retention, ileus ) and complications IPO questionnaire and analyzed by chi-square test and Fisher exact test. Scheffe correction will be applied for multiple comparison. Missing data are excluded from analysis.
The study has planned data monitoring and auditing by the IIS la Fe according to AEMPS guidelines. Registries will be obtained from electronic medical records available for double check procedures.
- Conditions
- Surgery, Breast Reconstruction
- Being tested
- Serrato, Control
- Keywords
- Oncological, Surgery, Breast, Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerratoProcedure or surgery
Serratus plane block.
ControlProcedure or surgery
Standard anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Serrato | Experimental | Standard anesthesia+serratus plane block. Receives: Procedure: Serrato |
| Control | Placebo comparator | Standard anesthesia Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Usage
Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.
Measured: First 24 hours after surgery
Secondary outcomes (3)
Pain at Rest and Coughing
Pain at rest and coughing at 24h postoperative (Visual analogue scale 0-10 with 0 meaning no pain and 10 meaning the worst imaginable pain). High score mean worse outcomes
Measured: First 24 hours after surgery
Time to First Opioid Administration on the Ward
Time to first opioid administration on the ward
Measured: First 24 hours after surgery
Presence of Opioid Related Complications
presence of nausea/vomit or apnea or urinary retention or ileus is assessed. It is a dicothomic composite (yes or no).
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start2 Aug 2016
- Primary completion8 Jun 2017
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Model description
- Two group parallel arm. With study group receiving regional anesthestic block with levobupivacaine and control group receiving standard care with intravenous analgesia only
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Mazzinari, Principal investigator, Instituto de Investigación Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905149
- Sponsor's protocol ID
- IBMS-SPB
- Status last verified
- Aug 2017
- First submitted
- 14 Sep 2016
- Last updated
- 2 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Minana JM, Belaouchi M. Interfascial block at the serratus muscle plane versus conventional analgesia in breast surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):52-58. doi: 10.1136/rapm-2018-000004.
PubMed 30640653
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast
- ClinicalTrials.gov ID
- NCT02905149
- Acronym / sponsor ID
- IBMS-SPB
- Conditions
- Surgery, Breast Reconstruction
- Keywords
- Oncological, Surgery, Breast, Reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 2 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on postoperative analgesia.
Detailed description
Regional analgesia techniques have shown to have benefits over conventional analgesia. The lower opioids analgesics requirements decrease side effects associated with the use of this type of medication. It is also increasingly established scientific evidence that reducing opioids administration may play a role in prognosis of cancer patients given the immunosuppressive effect of these drugs.
In patients undergoing oncologic/reconstructive breast surgery paravertebral block has been traditionally performed, however the paravertebral space lacks a clear anatomical barrier from the spinal cord so the drugs administered can diffuse to the intervertebral foramen causing deeper levels of blocks (epidural or spinal blocks) and injections at the paravertebral level are associated with serious complications both neurological and respiratory (meningitis, spinal hematomas abscesses, pneumothorax, respiratory failure. This has led to the development of less invasive technique with an improved safety profile.
The serratus plane block falls within the framework of these newly developed techniques and the present study aims to assess its role in the management of the patient undergoing cancer / reconstructive surgery.
Considering a decrease in postoperative morphine consumption of 40% and the average consumption of opioid after breast surgery under general anesthesia is 15 milligrams ( standard deviation 8 mg ) investigators calculated that with an alpha error 5% power 80 % 56 patients (28 per group) were required to achieve a significant result. In anticipation of possible loss of sample, 60 patients were recruited . Analysis will be performed by intention to treat.
Quantitative variables (opioid consumption, pain estimated by VAS scale) will be analyzed using mixed linear model adding a random variable for interindividual variability for pain threshold. If the data do not meet the criteria of normality the Mann-Whitney U test will be used. If the groups differ in preoperative variables. Investigators will make a multivariable analysis adjusting for these variables. The need for rescue analgesia over time is analyzed by Kaplan-Meier curve where the terminal state is the administration of the first dose of opioid postoperatively. The difference side effects (nausea, pruritus, apnea, urinary retention, ileus ) and complications IPO questionnaire and analyzed by chi-square test and Fisher exact test. Scheffe correction will be applied for multiple comparison. Missing data are excluded from analysis.
The study has planned data monitoring and auditing by the IIS la Fe according to AEMPS guidelines. Registries will be obtained from electronic medical records available for double check procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two group parallel arm. With study group receiving regional anesthestic block with levobupivacaine and control group receiving standard care with intravenous analgesia only
| Arm | Type | Receives |
|---|---|---|
| Serrato | Experimental | Procedure: SerratoStandard anesthesia+serratus plane block. |
| Control | Placebo comparator | Procedure: ControlStandard anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years, undergoing oncological surgery and/or breast reconstruction surgery whose pathology and surgical intervention supose at least a 24 hours hospital admission
Key exclusion criteria (2 listed)
- ASA Physical Status Classification System- IV.- Morbid obesity (Body mass index >40). -Impossibility of anatomical structures ultrasound identification in a satisfactory way (there can be no distinction in the interfascial plane between serratus and pectoral muscle). -Opioids treatment before surgery. Sepsis and/or infection at the puncture site.
- Haemostasis disorders. - Allergy to any of the drugs used in the 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 |
|---|---|---|
| SerratoSerratus plane block. | Procedure or surgery | Serrato |
| ControlStandard anesthesia | Procedure or surgery | Control |
Primary outcome
Total Opioid Usage
Time frame: First 24 hours after surgery
Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.
3 secondary outcomes
Pain at Rest and Coughing
Time frame: First 24 hours after surgery
Time to First Opioid Administration on the Ward
Time frame: First 24 hours after surgery
Presence of Opioid Related Complications
Time frame: First 24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30640653Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Minana JM, Belaouchi M. Interfascial block at the serratus muscle plane versus conventional analgesia in breast surgery: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):52-58. doi: 10.1136/rapm-2018-000004.
- Individual participant dataSharing planned: Undecided
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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.
Guido Mazzinari principal investigator
Instituto de Investigación Sanitaria La Fe
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 Serrato in people with Surgery and Breast Reconstruction, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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 2 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 2 Mar 2020. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Opioid Usage (time frame: First 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 NCT02905149, which also lists 1 linked publication.
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 2 Mar 2020.