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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
Results First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 19, 2016
Results First Submitted Date  ICMJE October 21, 2019
Results First Posted Date  ICMJE March 2, 2020
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE August 2, 2016
Actual Primary Completion Date June 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • Pain at Rest and Coughing [ Time Frame: First 24 hours after surgery ]
    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
  • Time to First Opioid Administration on the Ward [ Time Frame: First 24 hours after surgery ]
    Time to first opioid administration on the ward
  • Presence of Opioid Related Complications [ Time Frame: First 24 hours after surgery ]
    presence of nausea/vomit or apnea or urinary retention or ileus is assessed. It is a dicothomic composite (yes or no).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • 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).
  • Time to First Opioid Administration on the Ward [ Time Frame: First 24 hours after surgery ]
  • Opioid related complications [ Time Frame: First 24 hours after surgery ]
    (nausea/vomit, apnea, urinary retention, ileus)
  • Gender [ Time Frame: First 24 hours after surgery ]
  • Age [ Time Frame: First 24 hours after surgery ]
  • Weight [ Time Frame: First 24 hours after surgery ]
  • Height [ Time Frame: First 24 hours after surgery ]
  • Body mass index [ Time Frame: First 24 hours after surgery ]
  • American Society of Anesthesiologist surgical risk scale (from I to V) [ Time Frame: First 24 hours after surgery ]
  • Surgery duration (in minutes) [ Time Frame: First 24 hours after surgery ]
  • Surgical procedure [ Time Frame: First 24 hours after surgery ]
    (tumorectomy + sentinel lymph biopsy, simple mastectomy, radical mastectomy, axillary lymph exeresis)
  • Internation Pain [ Time Frame: First 24 hours after surgery ]
    Internation Pain Outcome questionnaire http://pain-out.med.uni-jena.de/.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
Official Title  ICMJE Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgery
  • Breast Reconstruction
Intervention  ICMJE
  • Procedure: Serrato
    Serratus plane block.
  • Procedure: Control
    Standard anesthesia
Study Arms  ICMJE
  • Experimental: Serrato
    Standard anesthesia+serratus plane block.
    Intervention: Procedure: Serrato
  • Placebo Comparator: Control
    Standard anesthesia
    Intervention: Procedure: Control
Publications * Mazzinari G, Rovira L, Casasempere A, Ortega J, Cort L, Esparza-Miñana 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 8, 2017
Actual Primary Completion Date June 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905149
Other Study ID Numbers  ICMJE IBMS-SPB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Instituto de Investigacion Sanitaria La Fe
Study Sponsor  ICMJE Instituto de Investigacion Sanitaria La Fe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guido Mazzinari Instituto de Investigación Sanitaria La Fe
PRS Account Instituto de Investigacion Sanitaria La Fe
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP