Hiatus Hernia, Laparoscopic, Rectointercostal
Conditions
Keywords
Ultrasound, Rectointercostal, Laparoscopic, Hiatus, Hernia
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.
Interventions
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).
OTHERNo Intervention as a control
General anesthesia without performing any block.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid consumption in the first 24 hours after surgery. | 24 hours after surgery. | opioid dose (morphine 0.05 mg/kg) will be given to patients with pain score ≥ 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 at rest and on movement from supine to sitting position. |
| 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. |
| Degree of patient satisfaction | 24 hour after surgery. | 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). |
Countries
Egypt
Outcome results
None listed