Inguinal Hernia
Conditions
Brief summary
The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).
Detailed description
Inguinal hernia repair accounts for 10-15% of all operations in general surgery. Moderate to severe pain can occur at the first day after inguinal hernia repair in 25% of patients at rest and in 60% during activity. On day 6 after the operation the incidence can be as high as 11% at rest and 33% during activity. Ultrasound imaging for regional anesthesia techniques have improved the success and safety rate of nerve blocks. We hypothesized that a procedure consisting of an ultrasound-guided inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block and incision line infiltration) could effectively control postoperative pain compared to selective unilateral subarachnoid anesthesia.
Interventions
OTHERTriple inguinal nerve block.
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
OTHERUnilateral subarachnoid anesthesia
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
Sponsors
Azienda Ospedaliera San Gerardo di Monza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* BMI (Body mass index) \< 30 * Non severe liver, renal or cardiac disease * No allergy or contraindications to any of the study drugs * American Hernia Society Score type I-II-IV-V hernia * No pain or chronic analgesic administration in the preoperative period * No previous surgery of the inguinal region * Normal coagulation parameters and platelet count (\> 100.000). * Dicumarol and aspirin suspension for \> 7 days * Correctly administrated premedication * No systemic infections * No contraindications to subarachnoid anesthesia
Exclusion criteria
* BMI (Body mass index) \> 30 * Severe liver, renal or cardiac disease * Allergy or contraindications to any of the study drugs * American Hernia Society Score type III-VI-VII-0 hernia * Pain or chronic analgesic administration in the preoperative period * Previous surgery of the inguinal region * Anormal coagulation parameters and platelet count (\< 100.000). * No dicumarol and aspirin suspension for \> 7 days * Incorrectly administrated premedication * Systemic infections * Contraindications to subarachnoid anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity. | Up to 24 hours. | Postoperative pain will be assessed by numeric ranking scale (numeric ranking scale NRS 0 to 10 points) at rest (static numeric ranking scale NRS) and during activity (dynamic numeric ranking scale NRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to general anesthesia. | During surgery, up to 2 hours | Patients will receive remifentanil adjusted to maintain spontaneous breathing and conscious sedation with a Ramsay score = 2 during surgery if modest pain (numeric ranking scale NRS \> 4 and agitation) is sustained. If remifentanil is not sufficient for restoring patient comfort, the block will be considered failed and the patient will be given general anesthesia with propofol and a Proseal Laryngeal Mask. |
| mPADSS (Post-Anesthesia Discharge Scoring System) | Up to 24 hours | Assessed at every evaluation time postoperatively. The modified Post-Anesthesia Discharge Scoring System (mPADSS) includes stable heart and respiratory rates, absence of excessive nausea and pain, no bleeding from the surgical site, and ability to walk without support. |
| Time from the end of anesthesia to first micturition. | Up to 24 hours. | Assessed at every evaluation time postoperatively. |
| Analgesic requirement | Up to 7 days | Assessed at every evaluation time postoperatively. |
| Supplemental local anesthesia infiltration | During surgery, up to 2 hours. | If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml. |
| Adverse events. | Up to 7 days | Assessed at every evaluation time and including surgical and anesthesiological related events. |
| Time from the end of surgery to the first unassisted walking. | Up to 24 hours. | Assessed at every evaluation time postoperatively. |
| Total intrahospital stay. | Up to 24 hours. | Assessed at every evaluation time postoperatively. |
| Activity | Up to 7 days | Assessed through the activities assessment questionnaire 7 days after surgery. |
Countries
Italy
Outcome results
None listed