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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
San Gerardo Hospital
Monza, Italy
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).
Time frame: Up to 24 hours.
Supplemental local anesthesia infiltration
If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 hours
Analgesic requirement
Assessed at every evaluation time postoperatively.
Time frame: Up to 7 days
Activity
Assessed through the activities assessment questionnaire 7 days after surgery.
Time frame: Up to 7 days
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Adverse events.
Assessed at every evaluation time and including surgical and anesthesiological related events.
Time frame: Up to 7 days
Time from the end of anesthesia to first micturition.
Assessed at every evaluation time postoperatively.
Time frame: Up to 24 hours.
Time from the end of surgery to the first unassisted walking.
Assessed at every evaluation time postoperatively.
Time frame: Up to 24 hours.
Total intrahospital stay.
Assessed at every evaluation time postoperatively.
Time frame: Up to 24 hours.