Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial

The aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (RIFPB) in epigastric hernia.

Study Overview

• Status: Completed
• Conditions: Analgesia; Epigastric Hernia; Recto-intercostal Fascial Plane Block
• Intervention / Treatment: Procedure: recto-intercostal fascial plane block; Drug: bupivacaine

Detailed Description

Epigastric hernias are usually occult in obese patients, and their symptoms may mimic peptic ulcer or gallbladder disease . Hernia repair is associated with considerable postoperative pain.

The recto-intercostal fascial plane block (RIFPB) is a new novel approach that was developed by Tulgar et al., 2023 who hypothesized that when we inject a local anesthetic into the interfacial plane just inferolateral to the xiphoid, between the rectus abdominis muscle and the 6-7th costal cartilages (hence, between the cartilages and the intercostal muscles between them), blockade of the anterior branches of the nerves passing through this area can be guaranteed.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Scheduled for elective epigastric hernia repair.

Exclusion Criteria:

• Obese patients with body mass index (BMI) >35 kg/m2.
• Patients with a large hernia containing bowel.
• Patients with local anesthetic allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIFPB group; Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.	Procedure: recto-intercostal fascial plane block; Patients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side.; Drug: bupivacaine; bupivacaine 0.25%
No Intervention: Control group; Patients will not receive the block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the 1st rescue analgesia	Rescue analgesia in the form of 3 mg of IV morphine will be given if the numeric rating scale (NRS) score > 3. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption in the 1st 24hr	Rescue analgesia in the form of 3 mg of IV morphine will be given if the numeric rating scale (NRS) score> 3.	24 hours postoperatively
Pain score	Each patient will be instructed about postoperative pain assessment with the Numeric Rating Scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). Postoperative pain using NRS at rest and during coughing or movement will be measured at PACU, 2h. 4hr, 6h, 8h, 12h, 18h and 24h postoperative	24 hours postoperatively
Intraoperative fentanyl consumption	Additional bolus doses of fentanyl 1 µg/kg IV will be given if there is increase in heart rate or mean arterial blood pressure more than 20% of the base line (after exclusion of other causes than pain).	Intraoperatively.
Intraoperative mean arterial pressure	Mean arterial pressure (MAP) will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery.
Intraoperative heart rate	Heart rate (HR) will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery.
Complications	Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2023
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: 36264PR330/9/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No