Analgesic Effect of Erector Spinae Plane Block After Caesarean Section (AnESPaCS)
Primary Purpose
Ceserean Section and Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
About this trial
This is an interventional treatment trial for Ceserean Section and Postoperative Pain focused on measuring Ceserean section, ESP block, postoperative pain
Eligibility Criteria
Inclusion Criteria:pregnant women,38-42 gestational weeks, ASA I-II
Exclusion Criteria:
- ≤18 or ≥45 age, has emergency obstetric surgery, pregnancy induced hypertension, significantly systematic disease, foetal or placental abnormality, hypersensitivity or allergy history to medicine to be used in the study, BMI≥35, autonomic neuropathy, diabetic, contraindicate to apply neuroachylic anaesthesia, who was transferred to general anaesthesia, could not decide or did not want to participate in the study, had severe respiratory and cardiac disease, was transferred to general anaesthesia, has infection, spine or chest wall deformity in operation area, has opioid dependence, chronic analgesic usage, inability to use a patient-controlled analgesia (PCA) device, couldn't be able to cooperative and express their pain with visual analogue scale score (VAS).
Sites / Locations
- Aysenur Dostbil
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
GROUP SA
GROUP SA+ESP
Arm Description
Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed
Group SA+ESP was categorized as group which SA+ESP block was performed.
Outcomes
Primary Outcome Measures
The primary outcome in this study was total opioid consumption for 24 hours.
Total fentanyl consumption postoperative 24 hours
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04599842
Brief Title
Analgesic Effect of Erector Spinae Plane Block After Caesarean Section
Acronym
AnESPaCS
Official Title
Analgesic Effect of Erector Spinae Plane Block After Caesarean Section: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk 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
Background: Our hypothesis was that bilateral ESP block applied from the transverse process of T9 in women who underwent elective cesarean section with pfannenstiel incision under spinal anesthesia could provide effective postoperative analgesia.The primary outcome in this study was total opioid consumption for 24 hours.
Material and Method: This randomized prospective study was carried out on 50 pregnant women who was scheduled for elective cesarean delivery via a Pfannenstiel incision with spinal anesthesia.Patients were randomly allocated in to two equal groups.Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed, Group SA+ESP was categorized as group which SA+ESP block was performed. All groups received 7 mg isobaric bupivacaine +15 µg fentanyl intrathecally through spinal anesthesia. The SA+ESP group, ESP block was performed at the ninth thoracic transverse process with 20 ml 0.25% bupivacaine + 2 mg dexamethasone immediately after the operation. Total fentanyl consumption in 24 hrs, visual analogue scale (VAS) score for pain, time to the first analgesic request were evaluated postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ceserean Section and Postoperative Pain
Keywords
Ceserean section, ESP block, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP SA
Arm Type
No Intervention
Arm Description
Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed
Arm Title
GROUP SA+ESP
Arm Type
Active Comparator
Arm Description
Group SA+ESP was categorized as group which SA+ESP block was performed.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Erector Spinae Plane block is performed by giving local anesthetic to the plan between the erector spinae muscle and the transverse process.
Primary Outcome Measure Information:
Title
The primary outcome in this study was total opioid consumption for 24 hours.
Description
Total fentanyl consumption postoperative 24 hours
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:pregnant women,38-42 gestational weeks, ASA I-II
Exclusion Criteria:
≤18 or ≥45 age, has emergency obstetric surgery, pregnancy induced hypertension, significantly systematic disease, foetal or placental abnormality, hypersensitivity or allergy history to medicine to be used in the study, BMI≥35, autonomic neuropathy, diabetic, contraindicate to apply neuroachylic anaesthesia, who was transferred to general anaesthesia, could not decide or did not want to participate in the study, had severe respiratory and cardiac disease, was transferred to general anaesthesia, has infection, spine or chest wall deformity in operation area, has opioid dependence, chronic analgesic usage, inability to use a patient-controlled analgesia (PCA) device, couldn't be able to cooperative and express their pain with visual analogue scale score (VAS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilker Ince, MD
Organizational Affiliation
Ataturk University, Department of Anesthesiology and Reanimation
Official's Role
Study Director
Facility Information:
Facility Name
Aysenur Dostbil
City
Yakutiye
State/Province
Erzurum
ZIP/Postal Code
25000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
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Analgesic Effect of Erector Spinae Plane Block After Caesarean Section
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