Analgesic Effect of Erector Spinae Plane Block After Caesarean Section

NCT04599842 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Ceserean section, ESP block, postoperative pain

Outcome Measures

Primary Outcomes (1)

• The primary outcome in this study was total opioid consumption for 24 hours.

  Total fentanyl consumption postoperative 24 hours

  24 hours

Study Arms (2)

GROUP SA

NO INTERVENTION

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

GROUP SA+ESP

ACTIVE COMPARATOR

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

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

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

GROUP SA+ESP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• ≤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).

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Aysenur Dostbil

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ilker Ince, MD

  Ataturk University, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 23, 2020
• Study Start: March 15, 2020
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

TU (1)