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

NCT06120088 | Unknown

• 1 other identifier: US-ESB for Postop Pain Control
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• first analgesic request

  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.

  baseline

Secondary Outcomes (1)

• VAS score

  baseline

Study Arms (3)

The Bupivacaine

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.

Drug: Bubpivacaine

The Bubpivacaine and 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

Drug: Bubpivacaine; Drug: dexamethasone

The Bubpivacaine and 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

Drug: Bubpivacaine; Drug: fentanyl

Interventions

Bubpivacaine DRUG

Bupivacaine is a long-acting local anesthetic commonly used to provide pain relief by blocking nerve signals in a specific area. It's often utilized for various medical procedures and surgeries, offering prolonged numbing effects.

The Bubpivacaine and dexamethasone; The Bubpivacaine and fentanyl; The Bupivacaine

dexamethasone DRUG

Dexamethasone is a potent corticosteroid with anti-inflammatory properties. It's frequently employed as an adjunct in medical treatments to reduce inflammation and swelling, and in some cases, to prevent nausea and vomiting associated with certain medications or procedures.

The Bubpivacaine and dexamethasone

fentanyl DRUG

Fentanyl is a powerful synthetic opioid pain reliever. It acts on the central nervous system to alleviate severe pain. Fentanyl is significantly potent and is used in medical settings for acute pain management, such as during surgeries or for chronic pain in cases where other opioids may not be as effective.

The Bubpivacaine and fentanyl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sample size was calculated using G power 3.1.9.2. To be able to calculate the difference in first analgesic request between the three studied groups with α error of 0.05, power of study of 0.9, equal group assignment and 0.4 effect size and using ANOVA test for comparison we need to include 27 patients in each group, another 3 patients will be added to each group to compensate for violation at the study protocol.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

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MeSH Terms

Interventions

Dexamethasone; Fentanyl

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Rehab Ahmed, master

CONTACT

01094878158; Rehabahmed5656@yahoo.com

Mahmoud Mohammed, prof

CONTACT

01006464560; Mahmoudkamel88.mk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11