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

Post Operative Pain Clinical Trial

Official title:

Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516901
• Other study ID #: 34579/3/21
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Fifty obese patient BMI (30-40).

• Aged (21-65) years ASA (?? and ???)

• 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.

Related Conditions & MeSH terms

• Diaphragmatic Dysfunction
• Erector Spinae Plane Block
• Hernia
• Hernia, Abdominal
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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.
• Control group
Patients in this group will receive general anesthesia alone.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	24 hours postoperatively
Secondary	Bradycardia	Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg	24 hours postoperatively