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

Primary Purpose

Epigastric Hernia Repair, Erector Spinae Plane Block, Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The erector spinae plane block group
Control group
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epigastric Hernia Repair

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The erector spinae plane block group

Control group

Arm Description

The erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block.

Control group (group І): Patients will receive general anesthesia alone.

Outcomes

Primary Outcome Measures

Post-operative pain
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.
Diaphragmatic dysfunction by physiological parameter
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

Secondary Outcome Measures

Hypotension
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.
Bradycardia
Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg

Full Information

First Posted
August 20, 2022
Last Updated
August 25, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05516901
Brief Title
Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Epigastric Hernia
Official Title
Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epigastric Hernia Repair, Erector Spinae Plane Block, Post Operative Pain, Diaphragmatic Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fifty obese patient BMI (30-40), aged (21-65) years ASA (ІΙ and ΙΙІ) and scheduled for elective Epigastric hernia repair were enrolled in the study.
Masking
ParticipantOutcomes Assessor
Masking Description
Group allocation was done by sealed opaque envelope technique. All blocks were performed by the same anesthesiologist while the measurements were taken by another anesthesiologist who is blinded to the study groups and had no subsequent involvement in the study.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The erector spinae plane block group
Arm Type
Experimental
Arm Description
The erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group (group І): Patients will receive general anesthesia alone.
Intervention Type
Procedure
Intervention Name(s)
The erector spinae plane block group
Intervention Description
The probe should then slowly be moved laterally until the transverse process is visible. The 100 mm, 25-gauge needle should be inserted using an in-plane approach in the cephalad to caudal direction and advanced under ultrasound guidance towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given. The erector spinae muscle should be visualized, separating from the transverse process. After aspiration the local anesthetic (20 ml of 0.25% bupivacaine was injected. Technique was repeated on the other side.
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
Patients in this group will receive general anesthesia alone.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
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.
Time Frame
24 hours postoperatively.
Title
Diaphragmatic dysfunction by physiological parameter
Description
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
Time Frame
24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Hypotension
Description
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.
Time Frame
24 hours postoperatively
Title
Bradycardia
Description
Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fifty obese patient BMI (30-40). Aged (21-65) years ASA (ІΙ and ΙΙІ) scheduled for elective Epigastric hernia repair 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.
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

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

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