Clinical trial NCT01521481: Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery
Official title: Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Lead sponsor: Azienda Ospedaliera San Gerardo di Monza
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 87
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity.
timeFrame: Up to 24 hours.
Secondary outcomes:
measure: Supplemental local anesthesia infiltration
timeFrame: During surgery, up to 2 hours.
measure: Conversion to general anesthesia.
timeFrame: During surgery, up to 2 hours
measure: mPADSS (Post-Anesthesia Discharge Scoring System)
timeFrame: Up to 24 hours
measure: Analgesic requirement
timeFrame: Up to 7 days
measure: Activity
timeFrame: Up to 7 days
measure: Adverse events.
timeFrame: Up to 7 days
measure: Time from the end of anesthesia to first micturition.
timeFrame: Up to 24 hours.
measure: Time from the end of surgery to the first unassisted walking.
timeFrame: Up to 24 hours.
measure: Total intrahospital stay.
timeFrame: Up to 24 hours.
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
Study officials:
affiliation: San Gerardo Hospital
name: Zhirajr Mokini, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: San Gerardo Hospital
name: Pablo Mauricio Ingelmo, M.D.
role: STUDY_DIRECTOR
References: