Analgesic Effect of Erector Spinae Plane Block After Caesarean Section

Ceserean Section and Postoperative Pain Clinical Trial

— AnESPaCS  

Official title:

Analgesic Effect of Erector Spinae Plane Block After Caesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599842
• Other study ID #: B.30.2.ATA.0.01.00/1
• Status: Completed
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: June 25, 2020

Study information

• Verified date: October 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 25, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ceserean Section and Postoperative Pain
• Pain, Postoperative

Intervention

Procedure:
• Erector Spinae Plane Block
Erector Spinae Plane block is performed by giving local anesthetic to the plan between the erector spinae muscle and the transverse process.

Locations

Country	Name	City	State
Turkey	Aysenur Dostbil	Yakutiye	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome in this study was total opioid consumption for 24 hours.	Total fentanyl consumption postoperative 24 hours	24 hours