Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair
Primary Purpose
Recto-intercostal Fascial Plane Block, Epigastric Hernia, Analgesia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
recto-intercostal fascial plane block
bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Recto-intercostal Fascial Plane Block
Eligibility Criteria
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.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RIFPB group
Control group
Arm Description
Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.
Patients will not receive the block.
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
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.
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
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).
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.
Intraoperative heart rate
Heart rate (HR) will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Complications
Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06092073
Brief Title
Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair
Official Title
Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recto-intercostal Fascial Plane Block, Epigastric Hernia, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIFPB group
Arm Type
Experimental
Arm Description
Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will not receive the block.
Intervention Type
Procedure
Intervention Name(s)
recto-intercostal fascial plane block
Intervention Description
Patients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
bupivacaine 0.25%
Primary Outcome Measure Information:
Title
Time to the 1st rescue analgesia
Description
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 Outcome Measure Information:
Title
Total morphine consumption in the 1st 24hr
Description
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
Title
Pain score
Description
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
Title
Intraoperative fentanyl consumption
Description
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.
Title
Intraoperative mean arterial pressure
Description
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.
Title
Intraoperative heart rate
Description
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.
Title
Complications
Description
Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed S ElSharkawy, MD
Phone
00201021559948
Email
mselsharkawy@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed S ElSharkawy, MD
Phone
00201021559948
Email
mselsharkawy@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Saad A Moharam, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
Learn more about this trial
Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair
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