Back to resultsInjection Rate and Erector Spinae Plane Block
Primary Purpose
Postoperative Pain, Breast Surgery
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard group
Long group
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Erector spinae plane (ESP) block, Postoperative Pain, Breast Surgery
Eligibility Criteria
Inclusion Criteria:
- aged between eighteen and sixty-five
- ASA I-III
- undergo elective breast cancer surgery
Exclusion Criteria:
- under 18 years of age or over 65 years of age
- ASA IV and above
- declined to give written informed consent
- contraindications of peripheral blocks or local anesthetic infiltration
- history of allergy against local anesthetics
- chronic pain history
- history of hepatic, neuromuscular, cardiac and/or renal failure
- infection at the injection site
Sites / Locations
- Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard group
Long group
Arm Description
standard injection rate will be applied
long injection rate will be applied
Outcomes
Primary Outcome Measures
Block sensory level
Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block
Secondary Outcome Measures
Postoperative tramadol consumption
Postoperative tramadol consumption will be recorded at 24 hours
Assesment of postoperative analgesia
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable).
Full Information
NCT ID
NCT04895072
First Posted
May 17, 2021
Last Updated
December 14, 2021
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04895072
Brief Title
Injection Rate and Erector Spinae Plane Block
Official Title
Effect of Injection Rate on the Block Sensory Level in the Erector Spine Plane Block
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the effect of injection rate on the block sensory level in the ESP block.
Detailed Description
Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Surgery
Keywords
Erector spinae plane (ESP) block, Postoperative Pain, Breast Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard group
Arm Type
Active Comparator
Arm Description
standard injection rate will be applied
Arm Title
Long group
Arm Type
Active Comparator
Arm Description
long injection rate will be applied
Intervention Type
Procedure
Intervention Name(s)
Standard group
Intervention Description
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.
Intervention Type
Procedure
Intervention Name(s)
Long group
Intervention Description
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.
Primary Outcome Measure Information:
Title
Block sensory level
Description
Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Postoperative tramadol consumption
Description
Postoperative tramadol consumption will be recorded at 24 hours
Time Frame
24 hours
Title
Assesment of postoperative analgesia
Description
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable).
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged between eighteen and sixty-five
ASA I-III
undergo elective breast cancer surgery
Exclusion Criteria:
under 18 years of age or over 65 years of age
ASA IV and above
declined to give written informed consent
contraindications of peripheral blocks or local anesthetic infiltration
history of allergy against local anesthetics
chronic pain history
history of hepatic, neuromuscular, cardiac and/or renal failure
infection at the injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Karaveli
Organizational Affiliation
Antalya TRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32517405
Citation
Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
Results Reference
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Injection Rate and Erector Spinae Plane Block
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