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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple inguinal nerve block | Experimental | Ropivacaine 5 mg/ml |
|
| Unilateral subarachnoid anesthesia | Active Comparator | Bupivacaine 10 mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple inguinal nerve block. | Other | Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity. | 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). | Up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Supplemental local anesthesia infiltration | If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml. | During surgery, up to 2 hours. |
| Conversion to general anesthesia. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhirajr Mokini, M.D. | San Gerardo Hospital | Principal Investigator |
| Pablo Mauricio Ingelmo, M.D. | San Gerardo Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Gerardo Hospital | Monza | 20900 | Italy |
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|
| Unilateral subarachnoid anesthesia | Other | Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia. |
|
|
| During surgery, up to 2 hours |
| mPADSS (Post-Anesthesia Discharge Scoring System) | 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. | Up to 24 hours |
| Analgesic requirement | Assessed at every evaluation time postoperatively. | Up to 7 days |
| Activity | Assessed through the activities assessment questionnaire 7 days after surgery. | Up to 7 days |
| Adverse events. | Assessed at every evaluation time and including surgical and anesthesiological related events. | Up to 7 days |
| Time from the end of anesthesia to first micturition. | Assessed at every evaluation time postoperatively. | Up to 24 hours. |
| Time from the end of surgery to the first unassisted walking. | Assessed at every evaluation time postoperatively. | Up to 24 hours. |
| Total intrahospital stay. | Assessed at every evaluation time postoperatively. | Up to 24 hours. |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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