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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serrato | Experimental | Standard anesthesia+serratus plane block. |
|
| Control | Placebo Comparator | Standard anesthesia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serrato | Procedure | Serratus plane block. |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | First 24 hours after surgery |
| Time to First Opioid Administration on the Ward |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Mazzinari | Instituto de Investigación Sanitaria La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Manises | Manises | Valencia | 46940 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30640653 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Serrato | Standard anesthesia+serratus plane block. Serrato: Serratus plane block. |
| FG001 | Control | Standard anesthesia Control: Standard anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Serrato | Standard anesthesia+serratus plane block. Serrato: Serratus plane block. |
| BG001 | Control | Standard anesthesia Control: Standard anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2 participants were lost to follow up because of malfunctioning of the electronic device administering the potoperative opioid | Posted | Median | 95% Confidence Interval | milligrams | First 24 hours after surgery |
|
24 hours after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serrato | Standard anesthesia+serratus plane block. Serrato: Serratus plane block. |
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The blinding method cannot entirely exclude ascertainment bias.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Cortell | Instituto de Investigación Sanitaria La Fe | 961246611 | investigacion_clinica@iislafe.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2016 | Oct 21, 2019 | Prot_SAP_000.pdf |
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Two group parallel arm. With study group receiving regional anesthestic block with levobupivacaine and control group receiving standard care with intravenous analgesia only
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| Procedure |
Standard anesthesia |
|
Time to first opioid administration on the ward |
| 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). | First 24 hours after surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | First 24 hours after surgery |
|
|
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| Secondary | Time to First Opioid Administration on the Ward | Time to first opioid administration on the ward | Posted | Mean | 95% Confidence Interval | hours | First 24 hours after surgery |
|
|
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| Secondary | 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). | Posted | Count of Participants | Participants | First 24 hours after surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Standard anesthesia Control: Standard anesthesia | 0 | 30 | 0 | 30 | 0 | 30 |
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| Pain interf. with activities in bed |
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| Pain interf. with breathing or coughing |
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