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Erector Spinae Block in Segmental Mastectomy.

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spinae block
Control group
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring regional anesthesia, erector spinae plane block, postoperative pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Being volunteer
  2. Over 18 years old
  3. Unilateral segmental mastectomy patients

Exclusion Criteria:

  1. Emergency operations
  2. Younger than 18 years old,
  3. Non Volunteers
  4. ASA 3 and 4 patients
  5. Non-cooperative patients

Sites / Locations

  • Maltepe University Medical FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP block group

Control group

Arm Description

Unilateral ESP block will be applied as postoperative regional analgesia technique in addition to the multimodal therapy. Then she is positioned in a right lateral position to perform ESP blocks. The skin will be disinfected and ESP block at one side will be performed in the lateral decubitus position and at T4 transverse process level by using 10-MHz linear ultrasound probe (Logic Ebook XP General Electrics, USA). The probe will be located 3 cm lateral to T4 spinous process in longitudinal parasagittal orientation. An 8 cm 21 gauge needle (BRAUN Stimuplex A®, Germany) will be inserted by using out of the plane technique. The ESP blocks proceed with 15 ml of 0,25% bupivacaine, 7,5 ml 1 % lidocaine, ,7,5 ml 0,9 % NaCl as total 30 ml . The injections will be applied after the confirmation of location by hidrodisection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.

In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia prepared with tramadol. Patient-controlled analgesia (PCA) with tramadol at 3mg/cc concentration is programmed with no basal infusion, demand dose 10 mg and 20-minute lock-out interval. Also, patients received 1 gr paracetamol in every 6 hours.

Outcomes

Primary Outcome Measures

postoperative anaglesic effect of ESPB in unilateral segmental mastectomy patients
Post operative pain scores will be recorded with NRS and opioid usage will be recorded

Secondary Outcome Measures

Full Information

First Posted
April 16, 2018
Last Updated
March 8, 2019
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03509090
Brief Title
Erector Spinae Block in Segmental Mastectomy.
Official Title
Evaluation of the Analgesic Efficacy of Ultrasound-guided Erector Spinae Block in Unilateral Breast Cancer Surgery: Randomized Controled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Erector spinae plane block (ESPB) is a recently described block. Although there is still no consensus of its mechanism, the published case series seems to promise a new regional anesthesia technique for both chronic and acute pain. In this clinical trial, the postoperative analgesic effect of ESPB will be studied in patients underwent unilateral breast cancer surgery.
Detailed Description
In this study 30 patients will be enrolled to study between March 2018-August 2018. All patient will be randomly selected who will be operated for breast cancer surgery between determined dates. Age, weight, ASA score, body mass index , additional dissease ststus will be recorded. The patients will be divided in two groups. One group will have ESPB at the end of the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 4/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be apllied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
regional anesthesia, erector spinae plane block, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESP block group
Arm Type
Active Comparator
Arm Description
Unilateral ESP block will be applied as postoperative regional analgesia technique in addition to the multimodal therapy. Then she is positioned in a right lateral position to perform ESP blocks. The skin will be disinfected and ESP block at one side will be performed in the lateral decubitus position and at T4 transverse process level by using 10-MHz linear ultrasound probe (Logic Ebook XP General Electrics, USA). The probe will be located 3 cm lateral to T4 spinous process in longitudinal parasagittal orientation. An 8 cm 21 gauge needle (BRAUN Stimuplex A®, Germany) will be inserted by using out of the plane technique. The ESP blocks proceed with 15 ml of 0,25% bupivacaine, 7,5 ml 1 % lidocaine, ,7,5 ml 0,9 % NaCl as total 30 ml . The injections will be applied after the confirmation of location by hidrodisection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia prepared with tramadol. Patient-controlled analgesia (PCA) with tramadol at 3mg/cc concentration is programmed with no basal infusion, demand dose 10 mg and 20-minute lock-out interval. Also, patients received 1 gr paracetamol in every 6 hours.
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Intervention Description
erector spinae block will be performed in this group as postoperative analgesia treatment.
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
patients will receive only multimodal analgesic treatment including patient-controlled analgesia
Primary Outcome Measure Information:
Title
postoperative anaglesic effect of ESPB in unilateral segmental mastectomy patients
Description
Post operative pain scores will be recorded with NRS and opioid usage will be recorded
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being volunteer Over 18 years old Unilateral segmental mastectomy patients Exclusion Criteria: Emergency operations Younger than 18 years old, Non Volunteers ASA 3 and 4 patients Non-cooperative patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onur Selvi, Dr
Phone
02164440620
Ext
2018
Email
prostel@yahoo.com
Facility Information:
Facility Name
Maltepe University Medical Faculty
City
Istanbul
ZIP/Postal Code
34843
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28188621
Citation
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Results Reference
background
PubMed Identifier
28492298
Citation
Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.
Results Reference
result

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Erector Spinae Block in Segmental Mastectomy.

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