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Different Volumes of Erector Spinae Plane Block for Breast Surgery

Primary Purpose

Breast Cancer, Breast Neoplasms, Breast Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine + Fentanyl
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Mastectomy and axillary dissection surgery, Postoperative pain management, Erector Spinae Plane Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for mastectomy and axillary dissection surgery under general anesthesia

Exclusion Criteria:

  • anticoagulant treatment,
  • known local anesthetic allergy,
  • infected skin around the block site,
  • pregnancy or breast-feeding,
  • back abnormalities

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 30 = 30 ml of Erector spinae plane block group

Group 20 = 20 ml of Erector spinae plane block group

Arm Description

In group 30 ml, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.

In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption (need and demand as microgram)
The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device. The parameters on PCA devices such as delivery and demand will be assessed

Secondary Outcome Measures

Pain scores (Visual analogue scores-VAS)
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded

Full Information

First Posted
January 14, 2022
Last Updated
May 26, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05232084
Brief Title
Different Volumes of Erector Spinae Plane Block for Breast Surgery
Official Title
Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol 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
Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.
Detailed Description
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations. The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Diseases
Keywords
Mastectomy and axillary dissection surgery, Postoperative pain management, Erector Spinae Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. The first group is 30 ml volume ESPB group. The second one is 20 ml volume ESPB group
Masking
ParticipantOutcomes Assessor
Masking Description
The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 30 = 30 ml of Erector spinae plane block group
Arm Type
Active Comparator
Arm Description
In group 30 ml, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.
Arm Title
Group 20 = 20 ml of Erector spinae plane block group
Arm Type
Active Comparator
Arm Description
In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine + Fentanyl
Intervention Description
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption (need and demand as microgram)
Description
The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device. The parameters on PCA devices such as delivery and demand will be assessed
Time Frame
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary Outcome Measure Information:
Title
Pain scores (Visual analogue scores-VAS)
Description
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded
Time Frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients who will undergo breast surgery will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for mastectomy and axillary dissection surgery under general anesthesia Exclusion Criteria: anticoagulant treatment, known local anesthetic allergy, infected skin around the block site, pregnancy or breast-feeding, back abnormalities
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not plan to share IPD
Citations:
PubMed Identifier
31280100
Citation
Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
Results Reference
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PubMed Identifier
30832580
Citation
Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3.
Results Reference
background
PubMed Identifier
32696226
Citation
Uda Y, Byrne K, Brahmbhatt A, Gotmaker R, Lim D, Konishi Y, Eves TK, Paxton E, Barrington MJ. A pilot randomized-controlled trial evaluating the erector spinae plane block in thoracic and breast surgery. Can J Anaesth. 2020 Oct;67(10):1371-1380. doi: 10.1007/s12630-020-01759-5. Epub 2020 Jul 21.
Results Reference
background
PubMed Identifier
32317873
Citation
Sharma S, Arora S, Jafra A, Singh G. Efficacy of erector spinae plane block for postoperative analgesia in total mastectomy and axillary clearance: A randomized controlled trial. Saudi J Anaesth. 2020 Apr-Jun;14(2):186-191. doi: 10.4103/sja.SJA_625_19. Epub 2020 Mar 5.
Results Reference
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Different Volumes of Erector Spinae Plane Block for Breast Surgery

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