Trials / Completed
CompletedNCT06820216
Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair
The Analgesic Effects of Ultrasound Guided Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair: A Double-Blind Randomized Controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Tanta University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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). |
| OTHER | No Intervention as a control | General anesthesia without performing any block. |
Timeline
- Start date
- 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 across 1 country: Egypt
Source: ClinicalTrials.gov record NCT06820216. Inclusion in this directory is not an endorsement.