The Analgesic Effects of Ultrasound Guided Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair: A Double-Blind Randomized Controlled Study
| Registry | NCT06820216 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 44 (Actual) |
| Sponsor | Tanta University (Other) |
| Conditions | Rectointercostal, Laparoscopic, Hiatus Hernia |
| Interventions | Rectointercostal facial plane block using bupivacaine 0.25%, No Intervention as a control (Drug, other) |
| Dates | start 2025-02-17, primary completion 2025-08-20, completion 2025-08-21, first posted 2025-02-11, last updated 2025-08-28 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Rectointercostal All trials for Laparoscopic All trials of Rectointercostal facial plane block using bupivacaine 0.25% All trials of No Intervention as a control
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 control | Patients will receive general anesthesia without any block. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Tanta University Hospitals | Tanta, Gharbia Governorate | Egypt |