Clinical trial NCT05516901: 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
Overall status: COMPLETED
Phase: NA
Conditions: Epigastric Hernia Repair
Erector Spinae Plane Block
Post Operative Pain
Diaphragmatic Dysfunction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-operative pain
timeFrame: 24 hours postoperatively.
measure: Diaphragmatic dysfunction by physiological parameter
timeFrame: 24 hours postoperatively.
Secondary outcomes:
measure: Hypotension
timeFrame: 24 hours postoperatively
measure: Bradycardia
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
References: