RectointercostalNCT06820216
Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair
A study testing Rectointercostal facial plane block using bupivacaine 0.25% in people with Rectointercostal and Laparoscopic, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the perioperative analgesic and intraoperative hemodynamic effects of ultrasound-guided bilateral recto-intercostal fascial plane block in patients undergoing laparoscopic Hiatus hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rectointercostal, Laparoscopic, Hiatus Hernia
- What is being tested?
- Rectointercostal facial plane block using bupivacaine 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2025to 21 Aug 2025
- 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 from 18 to 65 years.
- American Society of Anesthesiology (ASA) physical status I-II.
- Both sexes.
- Type 1 hiatus hernia (sliding hiatus hernia) with gastro-esophageal reflux disease and scheduled for elective laparoscopic hiatus hernia repair under general anesthesia.
Who cannot join
- Patients with cardiovascular, pulmonary, or neurological diseases.
- History of chronic pain or Long-term or recent use of opioids.
- Coagulation disorders or infection at the block application area.
- History of allergy to local anesthetic drugs.
- History of previous abdominal surgery.
- Pregnancy.
- Patients with gastro-esophageal reflux disease complicated by high grade esophagitis, esophageal stenosis or bleeding, and aspiration pneumonia or asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effects of Ultrasound Guided Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair: A Double-Blind Randomized Controlled Study
The aim of this study is to evaluate the perioperative analgesic and intraoperative hemodynamic effects of ultrasound-guided bilateral recto-intercostal fascial plane block in patients undergoing laparoscopic Hiatus hernia repair.
Read the detailed description
Hiatus hernia is a prevalent condition in which the stomach or other abdominal organs protrude through the esophageal hiatus of the diaphragm into the thoracic cavity due to elevated pressure within the abdomen. Laparoscopic hernioplasty of hiatal hernia has been confirmed effective and safe in recent years and performed more due to its mini-invasive nature and intraperitoneal view and operating angle.
Although patients having laparoscopic hiatus hernia repair experience less pain than open surgery, postoperative pain can still be significant and lead to associated postoperative issues. These issues can include respiratory and other complications, delay in discharge and adverse effects from increasing requirements of systemic analgesia such as opioid. An important consideration in the potential multitude of problems associated with increased opioid use is respiratory depression, sedation, constipation and the propensity for vomiting. Postoperative vomiting can result in the repaired diaphragm enduring excessive pressure and subsequently early recurrence and failure of the procedure.
Recently, a novel block named "recto-intercostal fascial plane block" is performed between the recto abdominal muscle and costal cartilages of ribs 6-7 to block the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators hypothesize that this block may provide perioperative analgesic benefits in patients undergoing Laparoscopic hiatus hernia repair under general anesthesia.
- Conditions
- Rectointercostal, Laparoscopic, Hiatus Hernia
- Being tested
- Rectointercostal facial plane block using bupivacaine 0.25%, No Intervention as a control
- Keywords
- Ultrasound, Rectointercostal, Laparoscopic, Hiatus, Hernia
- Medical subject headings
- Hernia, Hiatal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectointercostal facial plane block using bupivacaine 0.25%Drug
Ultrasound guided bilateral recto-intercostal facial plane block will be done after induction of general anesthesia using bupivacaine 0.25%. A linear ultrasound transducer Philips CX50 (5-14 MHz) will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area. The rectus abdominis muscle and its insertion, 6th and 7th cartilage ribs will be visualized. The needle will be inserted between rectus abdominis muscle and the costal cartilages with an in-plane technique in a caudal-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 20 ml of 0.25% bupivacaine will be injected, the same procedure will be then repeated with 20 ml 0.25% bupivacaine on the contra-lateral side (a total of 40 ml bilaterally).
No Intervention as a controlOther
General anesthesia without performing any block.
| Study group | Role | What they receive |
|---|---|---|
| Rectointercostal facial plane block group | Experimental | Patients will receive ultrasound-guided bilateral recto-intercostal facial plane block after induction of general anesthesia. Receives: Drug: Rectointercostal facial plane block using bupivacaine 0.25% |
| Control group | Other | Patients will receive general anesthesia without any block. Receives: Other: No Intervention as a control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid consumption in the first 24 hours after surgery.
opioid dose (morphine 0.05 mg/kg) will be given to patients with pain score ≥ 4.
Measured: 24 hours after surgery.
Secondary outcomes (5)
Intraoperative fentanyl consumption.
Intravenous fentanyl bolus dosages of 1 μg/kg will be administered if intraoperative heart rate or mean arterial blood pressure elevated more than 20% of the baseline
Measured: End of surgery.
Postoperative pain scores at post-anesthesia care unit arrival, 4 h, 8 h, 12 h, and 24 hour after surgery.
Numerical rating scale pain score (NRS) ranges from 0= no pain to 10= worst pain will be used to evaluate pain scores after surgery at rest and on movement from supine to sitting position.
Measured: 24 hours after surgery.
Time to first postoperative opioid analgesic request.
opioid dose will be given to patients with pain score ≥ 4.
Measured: 24 hours after surgery.
Side effects like postoperative nausea and vomiting, dysphagia and gas bloating after surgery
Any postoperative side effects will be reported.
Measured: 24 hours after surgery.
Degree of patient satisfaction
The degree of patient satisfaction will be assessed before discharge by the Likert patient satisfaction scale: (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Feb 2025
- Primary completion20 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RectointercostalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Eloraby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820216
- Sponsor's protocol ID
- 36264PR1064/1/25
- Status last verified
- Jan 2025
- First submitted
- 6 Feb 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author.
Publications
Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The analgesic effects of ultrasound-guided recto-intercostal fascial plane block in laparoscopic hiatus hernia repair: A randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2026 May;45(3):101724. doi: 10.1016/j.accpm.2025.101724. Epub 2025 Dec 3.
PubMed 41349840
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effects of Ultrasound Guided Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair: A Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06820216
- Acronym / sponsor ID
- 36264PR1064/1/25
- Conditions
- Rectointercostal, Laparoscopic, Hiatus Hernia
- Keywords
- Ultrasound, Rectointercostal, Laparoscopic, Hiatus, Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 11 Feb 2025 (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 perioperative analgesic and intraoperative hemodynamic effects of ultrasound-guided bilateral recto-intercostal fascial plane block in patients undergoing laparoscopic Hiatus hernia repair.
Detailed description
Hiatus hernia is a prevalent condition in which the stomach or other abdominal organs protrude through the esophageal hiatus of the diaphragm into the thoracic cavity due to elevated pressure within the abdomen. Laparoscopic hernioplasty of hiatal hernia has been confirmed effective and safe in recent years and performed more due to its mini-invasive nature and intraperitoneal view and operating angle.
Although patients having laparoscopic hiatus hernia repair experience less pain than open surgery, postoperative pain can still be significant and lead to associated postoperative issues. These issues can include respiratory and other complications, delay in discharge and adverse effects from increasing requirements of systemic analgesia such as opioid. An important consideration in the potential multitude of problems associated with increased opioid use is respiratory depression, sedation, constipation and the propensity for vomiting. Postoperative vomiting can result in the repaired diaphragm enduring excessive pressure and subsequently early recurrence and failure of the procedure.
Recently, a novel block named "recto-intercostal fascial plane block" is performed between the recto abdominal muscle and costal cartilages of ribs 6-7 to block the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators hypothesize that this block may provide perioperative analgesic benefits in patients undergoing Laparoscopic hiatus hernia repair under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectointercostal facial plane block group | Experimental | Drug: Rectointercostal facial plane block using bupivacaine 0.25%Patients will receive ultrasound-guided bilateral recto-intercostal facial plane block after induction of general anesthesia. |
| Control group | Other | Other: No Intervention as a controlPatients will receive general anesthesia without any 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 from 18 to 65 years.
- American Society of Anesthesiology (ASA) physical status I-II.
- Both sexes.
- Type 1 hiatus hernia (sliding hiatus hernia) with gastro-esophageal reflux disease and scheduled for elective laparoscopic hiatus hernia repair under general anesthesia.
Key exclusion criteria (7 listed)
- Patients with cardiovascular, pulmonary, or neurological diseases.
- History of chronic pain or Long-term or recent use of opioids.
- Coagulation disorders or infection at the block application area.
- History of allergy to local anesthetic drugs.
- History of previous abdominal surgery.
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 |
|---|---|---|
| Rectointercostal facial plane block using bupivacaine 0.25%Ultrasound guided bilateral recto-intercostal facial plane block will be done after induction of general anesthesia using bupivacaine 0.25%. A linear ultrasound transducer Philips CX50 (5-14 MHz) will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area. The rectus abdominis muscle and its insertion, 6th and 7th cartilage ribs will be visualized. The needle will be inserted between rectus abdominis muscle and the costal cartilages with an in-plane technique in a caudal-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 20 ml of 0.25% bupivacaine will be injected, the same procedure will be then repeated with 20 ml 0.25% bupivacaine on the contra-lateral side (a total of 40 ml bilaterally). | Drug | Rectointercostal facial plane block group |
| No Intervention as a controlGeneral anesthesia without performing any block. | Other | Control group |
Primary outcome
Total postoperative opioid consumption in the first 24 hours after surgery.
Time frame: 24 hours after surgery.
opioid dose (morphine 0.05 mg/kg) will be given to patients with pain score ≥ 4.
5 secondary outcomes
Intraoperative fentanyl consumption.
Time frame: End of surgery.
Postoperative pain scores at post-anesthesia care unit arrival, 4 h, 8 h, 12 h, and 24 hour after surgery.
Time frame: 24 hours after surgery.
Time to first postoperative opioid analgesic request.
Time frame: 24 hours after surgery.
Side effects like postoperative nausea and vomiting, dysphagia and gas bloating after surgery
Time frame: 24 hours after surgery.
Degree of patient satisfaction
Time frame: 24 hour after surgery.
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 28 Aug 2025.
- Derived from this study: PubMed 41349840Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The analgesic effects of ultrasound-guided recto-intercostal fascial plane block in laparoscopic hiatus hernia repair: A randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2026 May;45(3):101724. doi: 10.1016/j.accpm.2025.101724. Epub 2025 Dec 3.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author.
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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 Rectointercostal facial plane block using bupivacaine 0.25% in people with Rectointercostal and Laparoscopic, 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 7 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 28 Aug 2025. 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?
Total postoperative opioid consumption in the first 24 hours after surgery. (time frame: 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06820216, which also lists 1 linked publication.
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 28 Aug 2025.