Back to resultsErector Spinae Plane Block for Postoperative Pain Management
Primary Purpose
Pain, Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control
Erector spinae plane block
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, postoperative analgesia, Erector spinae plane block, cesarean section
Eligibility Criteria
Inclusion Criteria: ASA II patients 18-45 years who underwent CS with Pfannenstiel incision under spinal anesthesia agreed to participate in the study Exclusion Criteria: Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure patients with heart disease
Sites / Locations
- Kahramanmaras Sutcu Imam University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control group
Erector spinae plane block
Arm Description
No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Outcomes
Primary Outcome Measures
24-hour opioid consumption
The amount of tramadol consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Secondary Outcome Measures
Visual Analog Scale (Vas)
pain scores,graded from 0 to 10, 0 no pain, 10 highest pain experienced
Full Information
NCT ID
NCT05697315
First Posted
January 4, 2023
Last Updated
January 16, 2023
Sponsor
Kahramanmaras Sutcu Imam University
1. Study Identification
Unique Protocol Identification Number
NCT05697315
Brief Title
Erector Spinae Plane Block for Postoperative Pain Management
Official Title
The Effect of Erector Spinae Block for Postoperative Pain Management Cesarean Delivery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam 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 (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia.
Detailed Description
The study included 54 patients with mild systemic disease (ASA II patients) who would undergo elective CS under spinal anesthesia. They were randomly divided into an ESP block group (Group E) and a control group (Group C). After the surgery, Group E patients underwent ultrasound-guided bilateral ESP block with 20 ml of 0.25% bupivacaine at the lateral decubitus position, while Group C received no intervention. Patients in both groups received parenteral patient-controlled analgesia. The patients' post-operative 24-hour opioid consumption, regular Visual Analogue Scale (VAS) measurements, and need for rescue analgesics were evaluated. Statistical analysis was performed using SPSS 21 program. Demographic and other data were assessed using independent samples t-test, Mann-Whitney U test, and Chi-square analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative Pain
Keywords
Pain, postoperative analgesia, Erector spinae plane block, cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Double (Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
No block was performed
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Primary Outcome Measure Information:
Title
24-hour opioid consumption
Description
The amount of tramadol consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.
Time Frame
up to 24 hour
Secondary Outcome Measure Information:
Title
Visual Analog Scale (Vas)
Description
pain scores,graded from 0 to 10, 0 no pain, 10 highest pain experienced
Time Frame
0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA II patients
18-45 years who underwent CS with Pfannenstiel incision under spinal anesthesia
agreed to participate in the study
Exclusion Criteria:
Patients with infection at the injection site
Coagulopathy Allergy to amide-type local anesthetics
History of peripheral neuropathy
Hepatic and/or renal failure
Refusing the procedure
patients with heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökçe Gişi
Organizational Affiliation
Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaraş
ZIP/Postal Code
46100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Erector Spinae Plane Block for Postoperative Pain Management
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