Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

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

Detailed Description
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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.

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

Conditions
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Recto-intercostal Fascial Plane Block, Epigastric Hernia, Analgesia

Intervention / Treatment
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* Procedure: recto-intercostal fascial plane block
* Drug: bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIFPB group<br>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<br>* Patients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side.<br>Drug: bupivacaine<br>* bupivacaine 0.25%<br>|
| No Intervention: Control group<br>Patients will not receive the block. | |

What is the study measuring?
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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 |