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Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery

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ClinicalTrials.gov Identifier: NCT02905149
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Brief 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.

Condition or disease Intervention/treatment Phase
Surgery Breast Reconstruction Procedure: Serrato Procedure: Control Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : July 8, 2017

Arm Intervention/treatment
Experimental: Serrato
Standard anesthesia+serratus plane block.
Procedure: Serrato
Serratus plane block.

Placebo Comparator: Control
Standard anesthesia
Procedure: Control
Standard anesthesia




Primary Outcome Measures :
  1. Total opioid usage [ Time Frame: First 24 hours after surgery ]
    Total opioid usage first 24 hours (intra and postoperative) (in morphine mgs, fentanyl/morphine conversion = 10 mcgs/1mg)


Secondary Outcome Measures :
  1. Pain at rest and coughing [ Time Frame: First 24 hours after surgery ]
    Pain at rest and coughing at 1h, 3h, 6h, 12h, 24h postoperative (Visual analogue scale 0-10).

  2. Time to first opioid administration on the ward [ Time Frame: First 24 hours after surgery ]
    Time to first opioid administration on the ward

  3. Opioid related complications [ Time Frame: First 24 hours after surgery ]
    (nausea/vomit, apnea, urinary retention, ileus)

  4. Gender [ Time Frame: First 24 hours after surgery ]
    Gender

  5. Age [ Time Frame: First 24 hours after surgery ]
    Age

  6. Weight [ Time Frame: First 24 hours after surgery ]
    Weight

  7. Height [ Time Frame: First 24 hours after surgery ]
    Height

  8. Body mass index [ Time Frame: First 24 hours after surgery ]
    Body mass index

  9. American Society of Anesthesiologist surgical risk scale (from I to V) [ Time Frame: First 24 hours after surgery ]
    ASA ≥ IV

  10. Surgery duration (in minutes) [ Time Frame: First 24 hours after surgery ]
    Surgery duration (in minutes)

  11. Surgical procedure [ Time Frame: First 24 hours after surgery ]
    (tumorectomy + sentinel lymph biopsy, simple mastectomy, radical mastectomy, axillary lymph exeresis)

  12. Internation Pain [ Time Frame: First 24 hours after surgery ]
    Internation Pain Outcome questionnaire http://pain-out.med.uni-jena.de/.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905149


Locations
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Spain
Hospital de Manises
Manises, Valencia, Spain, 46940
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Guido Mazzinari Instituto de Investigación Sanitaria La Fe

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT02905149     History of Changes
Other Study ID Numbers: IBMS-SPB
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Oncological
Surgery
Breast
Reconstruction
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs