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CompletedNCT06092073Updated Jul 14, 2026

Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

An interventional study of recto-intercostal fascial plane block and bupivacaine in Recto-intercostal Fascial Plane Block, Epigastric Hernia and Analgesia, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Recto-intercostal Fascial Plane Block
  • Epigastric Hernia
  • Analgesia

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03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 507 are open to participants now.

This study's enrollment of 40 is below the median of 77 across 1,023 interventional studies indexed under Agnosia.

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Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Obese patients with body mass index (BMI) >35 kg/m2.
  • Patients with a large hernia containing bowel.
  • Patients with local anesthetic allergy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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 · Drug: bupivacaine

  • No intervention
    Control group

    Patients will not receive the block.

Interventions

  • Procedurerecto-intercostal fascial plane block

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

  • Drugbupivacaine

    bupivacaine 0.25%

06

What researchers measure

Primary outcomes

  1. 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").

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. 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.

    Time frame: 24 hours postoperatively

  2. 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

    Time frame: 24 hours postoperatively

  3. 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).

    Time frame: Intraoperatively.

  4. 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.

    Time frame: Till the end of surgery.

  5. Intraoperative heart rate

    Heart rate (HR) will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

    Time frame: Till the end of surgery.

  6. Complications

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

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06092073
Lead sponsor
Tanta University
Responsible party
Mohammed Said ElSharkawy (Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University) — Principal investigator
First posted
Oct 23, 2023
Start date
Oct 21, 2023
Primary completion
May 31, 2026
Completion
May 31, 2026
Last update
Jul 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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