Clinical trial NCT06820216: Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair
Official title: The Analgesic Effects of Ultrasound Guided Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair: A Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectointercostal
Laparoscopic
Hiatus Hernia
Keywords: Ultrasound
Rectointercostal
Laparoscopic
Hiatus
Hernia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total postoperative opioid consumption in the first 24 hours after surgery.
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: Intraoperative fentanyl consumption.
timeFrame: End of surgery.
measure: Postoperative pain scores at post-anesthesia care unit arrival, 4 h, 8 h, 12 h, and 24 hour after surgery.
timeFrame: 24 hours after surgery.
measure: Time to first postoperative opioid analgesic request.
timeFrame: 24 hours after surgery.
measure: Side effects like postoperative nausea and vomiting, dysphagia and gas bloating after surgery
timeFrame: 24 hours after surgery.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbia
Study officials:
References: