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

November 1, 2023 updated by: Rehab Ahmed Hussien, Assiut University

U.S Guided Erector Spinae Block for Postoperative Pain Control in Patients Undergoing Para Umblical Hernial Repair. (Comparative Study ).

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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.
Drug: dexamethasone
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 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
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.
Drug: fentanyl
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first analgesic request
Time Frame: 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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-ESB for Postop Pain Control

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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