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

NCT ID: NCT05516901

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Epigastric Hernia Repair Erector Spinae Plane Block Post Operative Pain Diaphragmatic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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The erector spinae plane block group

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

Group Type EXPERIMENTAL

The erector spinae plane block group

Intervention Type PROCEDURE

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.

Control group

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

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type PROCEDURE

Patients in this group will receive general anesthesia alone.

Interventions

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The erector spinae plane block group

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

Control group

Patients in this group will receive general anesthesia alone.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Ragab Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34579/3/21

Identifier Type: -

Identifier Source: org_study_id

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