Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair

Not Applicable

Recruiting

• Conditions: Rectointercostal; Laparoscopic; Hiatus Hernia
• Interventions: Drug: Rectointercostal facial plane block using bupivacaine 0.25%; Other: No Intervention as a control

• Registration Number: NCT06820216
• Lead Sponsor: Tanta University

Brief 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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Study Start: 2025-02-17
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-08-17
• Study Completion: 2025-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Age from 18 to 65 years.
• American Society of Anesthesiology (ASA) physical status I-II.
• Both sexes.
• Scheduled for elective elective laparoscopic hiatus hernia repair under general anesthesia.

Exclusion Criteria

• Patients with cardiovascular, pulmonary, or neurological diseases.
• History of chronic pain or Long-term or recent use of opioids.
• Coagulation disorders.
• History of allergy to local anesthetic drugs.
• History of previous abdominal surgery.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectointercostal facial plane block group	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	No Intervention as a control	Patients will receive general anesthesia without any block.

Primary Outcome Measures

Name	Time	Method
Total postoperative opioid consumption in the first 24 hours after surgery.	24 hours after surgery.	opioid dose will be given to patients with pain score ≥ 4.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption.	End of surgery.	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
Postoperative pain scores at post-anesthesia care unit arrival, 4 h, 8 h, 12 h, and 24 hour after surgery.	24 hours 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.
Time to first postoperative opioid analgesic request.	24 hours after surgery.	opioid dose will be given to patients with pain score ≥ 4.
Side effects like postoperative nausea and vomiting, dysphagia and gas bloating after surgery	24 hours after surgery.	Any postoperative side effects will be reported.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbia, Egypt