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OpenTrials
Completed

NCT Number: NCT04599842

Analgesic Effect of Erector Spinae Plane Block After Caesarean Section

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aysenur Dostbil

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 24 hours

    Total fentanyl consumption postoperative 24 hours

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: AnESPaCS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2020
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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