Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092073
• Other study ID #: 36264PR330/9/23
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mohammed S ElSharkawy, MD
• Phone: 00201021559948
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Epigastric Hernia
• Hernia
• Hernia, Abdominal

Intervention

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%

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Complications	Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.	24 hours postoperatively