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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06120088

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Regional Anesthesia	Drug: Bubpivacaine Drug: dexamethasone Drug: fentanyl

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	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.

Arm

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

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rehab Ahmed Hussien, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT06120088

Other Study ID Numbers:

US-ESB for Postop Pain Control

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Dexamethasone

Fentanyl

Study Results

No Results Posted as of Nov 7, 2023