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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06092073
Other study ID # 36264PR330/9/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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