Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

Not Applicable

Recruiting

• Conditions: Recto-intercostal Fascial Plane Block; Epigastric Hernia; Analgesia
• Interventions: Procedure: recto-intercostal fascial plane block; Drug: bupivacaine

• Registration Number: NCT06092073
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-19
• Study Start: 2023-10-21
• Study First Posted: 2023-10-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIFPB group	recto-intercostal fascial plane block	Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.
RIFPB group	bupivacaine	Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	24 hours postoperatively	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").

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperatively.	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).
Pain score	24 hours postoperatively	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
Total morphine consumption in the 1st 24hr	24 hours postoperatively	Rescue analgesia in the form of 3 mg of IV morphine will be given if the numeric rating scale (NRS) score\> 3.
Intraoperative mean arterial pressure	Till the end of surgery.	Mean arterial pressure (MAP) will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Intraoperative heart rate	Till the end of surgery.	Heart rate (HR) will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Complications	24 hours postoperatively	Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt