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

NCT05516901 | Completed

• 1 other identifier: 34579/3/21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hours postoperatively.

• 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

  24 hours postoperatively.

Secondary Outcomes (2)

• Hypotension

  24 hours postoperatively

• Bradycardia

  24 hours postoperatively

Study Arms (2)

The erector spinae plane block group

EXPERIMENTAL

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

Procedure: The erector spinae plane block group

Control group

PLACEBO COMPARATOR

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

Procedure: Control group

Interventions

The erector spinae plane block group 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.

The erector spinae plane block group

Control group PROCEDURE

Patients in this group will receive general anesthesia alone.

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: August 26, 2022
• Study Start: July 1, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

EG (1)