Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06092073
Collaborator
(none)
40
1
2
4.3
9.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial
Actual Study Start Date :
Oct 21, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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).

  4. 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.

  5. 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.

  6. Complications [24 hours postoperatively]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:
  • Obese patients with body mass index (BMI) >35 kg/m2.

  • Patients with a large hernia containing bowel.

  • Patients with local anesthetic allergy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Tanta El-Gharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Said ElSharkawy, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT06092073
Other Study ID Numbers:
  • 36264PR330/9/23
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023