Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Epigastric Hernia

Not Applicable

Completed

• Conditions: Post Operative Pain; Epigastric Hernia Repair; Diaphragmatic Dysfunction; Erector Spinae Plane Block
• Interventions: Procedure: Control group; Procedure: The erector spinae plane block group

• Registration Number: NCT05516901
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to assess the efficacy of ultrasound guided erector Spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing Epigastric hernia repair.

Detailed Description

Ventral hernia repair is an operation associated with significant postoperative pain. There is a lot of modalities of pain control including regional anesthesia, intravenous opioids, and non-opioid analgesics. Regional anesthesia is often helpful in improving respiratory function and analgesia.

The dysfunction of the respiratory muscles, especially the diaphragm, caused by the upper abdominal surgery is a major cause of postoperative pulmonary complications, such as atelectasis and pneumonia. Sonografic evaluation of diaphragm is an accepted qualitative method of assessing diaphragmatic motion.

The erector spinae plane block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the transverse processes, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.

According to previous studies, erector spinae plane block provide lower postoperative pain score and decrease consumption of both postoperative and intraoperative analgesia for patients undergoing Epigastric hernia repair.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-20
• Study First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Fifty obese patient BMI (30-40).
• Aged (21-65) years ASA (ІΙ and ΙΙІ)
• scheduled for elective Epigastric hernia repair

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Exclusion Criteria

• Patient refusal to continue the study.
• History of allergy to local anesthetics.
• Local infection at the site of the block.
• Patients with bleeding and coagulation disorders.
• Patients with renal, hepatic, cardiac dysfunction, or spine deformities.
• Patients with cognitive disorders.
• Patients with chronic pulmonary disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Control group (group І): Patients will receive general anesthesia alone.
The erector spinae plane block group	The erector spinae plane block group	The erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block.

Primary Outcome Measures

Name	Time	Method
Diaphragmatic dysfunction by physiological parameter	24 hours postoperatively.	After recovery, patient laid in the supine position and diaphragm movements were recorded in the B-Mode and M-Mode. The probe was positioned between the midclavicular and anterior axillary lines, in the subcostal area, so that the ultrasound beam entered the posterior third of the right hemi diaphragm perpendicularly.; After correct visualization of the right hemidiaphragm by B-mode, M-mode is used to display the motion of the diaphragm. At the end of normal expiration the patient was instructed to inhale as deeply as possible. A fixed point at the edge of the image on the screen and the diaphragm margin at maximal inspiration and again at maximal expiration served as reference points between which measurements were made, with the average of three values being taken for both maximal inspiration and maximal expiration
Post-operative pain	24 hours postoperatively.	Post-operative pain will be assessed by Numeric Rating Scale at recovery room till 24 hours and if NRS˃3 morphine 3 mg will be given, total analgesics required will be recorded.

Secondary Outcome Measures

Name	Time	Method
Bradycardia	24 hours postoperatively	Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg
Hypotension	24 hours postoperatively	defined as decrease blood pressure more than 20% of base line It was treated with rapid IV fluid infusion (100ml over 1 minutes) and bolus ephedrine 5-15 mg if needed.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbia, Egypt