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

• 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: Instituto de Investigacion Sanitaria La Fe
• Information provided by (Responsible Party): Instituto de Investigacion Sanitaria La Fe

Tracking Information

• First Submitted Date: September 14, 2016
• First Posted Date: September 19, 2016
• Results First Submitted Date: October 21, 2019
• Results First Posted Date: March 2, 2020
• Last Update Posted Date: March 2, 2020
• Actual Study Start Date: August 2, 2016
• Actual Primary Completion Date: June 8, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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)

Current Secondary Outcome Measures (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 (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: Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
• Official Title: 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: Interventional
• Study Phase: Phase 4

Study Design

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

• Surgery
• Breast Reconstruction

Intervention

• Procedure: Serrato
  Serratus plane block.
• Procedure: Control
  Standard anesthesia

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 16, 2016): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 8, 2017
• Actual Primary Completion Date: June 8, 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02905149
• Other Study ID Numbers: IBMS-SPB
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Instituto de Investigacion Sanitaria La Fe
• Study Sponsor: Instituto de Investigacion Sanitaria La Fe
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guido Mazzinari; Instituto de Investigación Sanitaria La Fe

• PRS Account: Instituto de Investigacion Sanitaria La Fe
• Verification Date: August 2017