Analgesic Effect of Erector Spinae Plane Block After Caesarean Section

NCT ID: NCT04599842

Last Updated: 2020-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2020-06-25

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.

Conditions

Ceserean Section and Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GROUP SA

Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

GROUP SA+ESP

Group SA+ESP was categorized as group which SA+ESP block was performed.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Aysenur Dostbil

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilker Ince, MD

Role: STUDY_DIRECTOR

Ataturk University, Department of Anesthesiology and Reanimation

Locations

Aysenur Dostbil

Yakutiye, Erzurum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ATA.0.01.00/1

Identifier Type: -

Identifier Source: org_study_id