Recto-intercostal Fascial Plane BlockNCT06092073
Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair
A study testing recto-intercostal fascial plane block and bupivacaine in people with Recto-intercostal Fascial Plane Block and Epigastric Hernia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (RIFPB) in epigastric hernia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recto-intercostal Fascial Plane Block, Epigastric Hernia, Analgesia
- What is being tested?
- recto-intercostal fascial plane block and bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for elective epigastric hernia repair.
Who cannot join
- Obese patients with body mass index (BMI) >35 kg/m2.
- Patients with a large hernia containing bowel.
- Patients with local anesthetic allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial
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.
- Being tested
- recto-intercostal fascial plane block, bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recto-intercostal fascial plane blockProcedure or surgery
Patients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side.
bupivacaineDrug
bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| RIFPB group | Experimental | Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side. Receives: Procedure: recto-intercostal fascial plane block; Drug: bupivacaine |
| Control group | No intervention | Patients will not receive the block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 24 hours postoperatively
Secondary outcomes (6)
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.
Measured: 24 hours postoperatively
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
Measured: 24 hours postoperatively
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).
Measured: Intraoperatively.
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.
Measured: 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.
Measured: Till the end of surgery.
Complications
Such as pneumothorax, nausea, vomiting, hematoma, hypotension, bradycardia and local anesthetic toxicity will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start21 Oct 2023
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recto-intercostal Fascial Plane BlockStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092073
- Sponsor's protocol ID
- 36264PR330/9/23
- Status last verified
- Jul 2026
- First submitted
- 12 Oct 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06092073
- Acronym / sponsor ID
- 36264PR330/9/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIFPB group | Experimental | Procedure: recto-intercostal fascial plane block, Drug: bupivacainePatients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side. |
| Control group | No intervention | –Patients will not receive the block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for elective epigastric hernia repair.
Key exclusion criteria (3 listed)
- Obese patients with body mass index (BMI) >35 kg/m2.
- Patients with a large hernia containing bowel.
- Patients with local anesthetic allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recto-intercostal fascial plane blockPatients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side. | Procedure or surgery | RIFPB group |
| bupivacainebupivacaine 0.25% | Drug | RIFPB group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 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").
6 secondary outcomes
Total morphine consumption in the 1st 24hr
Time frame: 24 hours postoperatively
Pain score
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively.
Intraoperative mean arterial pressure
Time frame: Till the end of surgery.
Intraoperative heart rate
Time frame: Till the end of surgery.
Complications
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recto-intercostal fascial plane block and bupivacaine in people with Recto-intercostal Fascial Plane Block and Epigastric Hernia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the 1st rescue analgesia (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.