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NCT Number: NCT06092073

Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

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

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Key information

Conditions

Recto-intercostal Fascial Plane Block Agnosia Analgesia Epigastric Hernia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recto-Intercostal Fascial Plane Block

Procedure

Patients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side.

Bupivacaine

Drug

bupivacaine 0.25%

Primary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 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 outcomes

  1. Total morphine consumption in the 1st 24hr

    Time frame: 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.

  2. Pain score

    Time frame: 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

  3. Intraoperative fentanyl consumption

    Time frame: 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).

  4. Intraoperative mean arterial pressure

    Time frame: 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.

  5. Intraoperative heart rate

    Time frame: 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.

  6. Complications

    Time frame: 24 hours postoperatively

    Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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