U.S. Guided Erector Spinae Block for Postoperative Pain Management in Paraumbilical Hernia Repair Patients

Not yet recruiting

• Conditions: Regional Anesthesia
• Interventions: Drug: Bubpivacaine; Drug: fentanyl; Drug: dexamethasone

• Registration Number: NCT06120088
• Lead Sponsor: Assiut University

Brief Summary

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period. Although opioids are commonly used for analgesia after paraumbilical hernia, they can lead to side effects, such as nausea and vomiting, constipation, pruritus, and life-threatening respiratory depression. Regional anesthetic techniques are commonly used to prevent or minimize these side effects. The objective of this study is to assess the effectiveness of erector spinae plane block (ESPB) and standard medical (no block) pain management after paraumbilical hernia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Start: 2023-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age group : 18-60 years old
• Both genders
• Patient scheduled for paraumbilical hernia surgeries

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Exclusion Criteria

• Allergy to medications used in this study
• Patient's refusal to participate in this study
• Recurrent cases
• Any complications to local blocks
• Emergency surgical procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Bupivacaine	Bubpivacaine	Patients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% on each side + 1ml saline placebo.
The Bubpivacaine and dexamethasone	Bubpivacaine	Patients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% plus 1ml dexamethasone on each side
The Bubpivacaine and fentanyl	Bubpivacaine	Patients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% in addition to calculated dose of fentanyl on each side
The Bubpivacaine and fentanyl	fentanyl	Patients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% in addition to calculated dose of fentanyl on each side
The Bubpivacaine and dexamethasone	dexamethasone	Patients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% plus 1ml dexamethasone on each side

Primary Outcome Measures

Name	Time	Method
first analgesic request	baseline	signifies the initial instance when a patient asks for pain relief, commonly occurring post-surgery or during medical care, marking the first acknowledgment or complaint of discomfort prompting the need for pain medication or management.

Secondary Outcome Measures

Name	Time	Method
VAS score	baseline	a quantitative measure used in healthcare to assess and quantify pain levels. It involves a patient marking their perceived pain intensity on a 10-point or 100-point scale, typically from "no pain" to "worst pain imaginable," providing a straightforward and subjective representation of pain severity.