San Gerardo Hospital
Monza, 20900, Italy
NCT Number: NCT01521481
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).
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Notify Me18 year–90 year
Male
Interventional
Phase 4
Monza, 20900, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
Other names: Regional anesthesia for the groin.
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
Other names: Regional anesthesia for the groin.
Time frame: 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).
Time frame: During surgery, up to 2 hours.
If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
Time frame: 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.
Time frame: 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 frame: Up to 7 days
Assessed at every evaluation time postoperatively.
Time frame: Up to 7 days
Assessed through the activities assessment questionnaire 7 days after surgery.
Time frame: Up to 7 days
Assessed at every evaluation time and including surgical and anesthesiological related events.
Time frame: Up to 24 hours.
Assessed at every evaluation time postoperatively.
Time frame: Up to 24 hours.
Assessed at every evaluation time postoperatively.
Time frame: Up to 24 hours.
Assessed at every evaluation time postoperatively.
Azienda Ospedaliera San Gerardo di Monza
Other
Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.
Acronym: U-IFB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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