An interventional study of Rectointercostal facial plane block using bupivacaine 0.25% and No Intervention as a control in Rectointercostal, Laparoscopic and Hiatus Hernia, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Tanta University · Not applicable, Interventional, and Prevention
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.
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's enrollment of 44 is below the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
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Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive ultrasound-guided bilateral recto-intercostal facial plane block after induction of general anesthesia.
Drug: Rectointercostal facial plane block using bupivacaine 0.25%
Patients will receive general anesthesia without any block.
Other: No Intervention as a control
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).
General anesthesia without performing any block.
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.
Time frame: 24 hours after surgery.
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
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.
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.
Time frame: 24 hours after surgery.
Time to first postoperative opioid analgesic request.
opioid dose will be given to patients with pain score ≥ 4.
Time frame: 24 hours after surgery.
Side effects like postoperative nausea and vomiting, dysphagia and gas bloating after surgery
Any postoperative side effects will be reported.
Time frame: 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).
Time frame: 24 hour after surgery.
Plan to share: Yes — The data will be available upon reasonable request from the corresponding author.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After completion of the study.
Access criteria: The data will be available upon reasonable request from the corresponding author.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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