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Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery

Primary Purpose

Postoperative Pain, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intravenous morphine patient controlled device
Erector Spinae Plane Block
Thoracic Paravertebral Block
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring erector spinae plane block, thoracic paravertebral block, breast surgery, postoperative pain

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 25-70 years of agge
  • ASA I-II
  • Undergoing elective breast cancer surgery

Exclusion Criteria:

  • obesity (body mass index >35 kg/m2)
  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • recent use of analgesic drugs

Sites / Locations

  • Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

ESP group

TPVB group

Control Group

Arm Description

Erector Spinae Plane Block administered group

Thoracic Paravertebral Block administered group

No regional anesthesia technique will be applied to control group; but will be provided with iv PCA

Outcomes

Primary Outcome Measures

Morphine consumption
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.

Secondary Outcome Measures

Numering Rating Scale scores for pain
Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting will be recorded

Full Information

First Posted
March 18, 2018
Last Updated
August 27, 2018
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03480958
Brief Title
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Official Title
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran 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 analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Cancer
Keywords
erector spinae plane block, thoracic paravertebral block, breast surgery, postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP group
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block administered group
Arm Title
TPVB group
Arm Type
Active Comparator
Arm Description
Thoracic Paravertebral Block administered group
Arm Title
Control Group
Arm Type
Other
Arm Description
No regional anesthesia technique will be applied to control group; but will be provided with iv PCA
Intervention Type
Device
Intervention Name(s)
Intravenous morphine patient controlled device
Intervention Description
24 hour morphine consumption will be recorded
Intervention Type
Other
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
erector spinae plane block will be administered before the surgery
Intervention Type
Other
Intervention Name(s)
Thoracic Paravertebral Block
Intervention Description
thoracic paravertebral block will be administered before the surgery
Primary Outcome Measure Information:
Title
Morphine consumption
Description
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
Numering Rating Scale scores for pain
Description
Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain
Time Frame
24 hour
Title
Postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting will be recorded
Time Frame
24h

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25-70 years of agge ASA I-II Undergoing elective breast cancer surgery Exclusion Criteria: obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic drugs
Facility Information:
Facility Name
Kocaeli University Hospital
City
Kocaeli
ZIP/Postal Code
41340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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
derived

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Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery

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