Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery (U-IFB)

Azienda Ospedaliera San Gerardo di Monza

Status and phase: Completed; Phase 4

Conditions: Inguinal Hernia

Treatments: Other: Unilateral subarachnoid anesthesia; Other: Triple inguinal nerve block.

Study type: Interventional

Funder types: Other

Identifiers

NCT01521481

AR HSG 03 2010

Details and patient eligibility

About

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).

Full 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.

Enrollment: 87 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Triple inguinal nerve block

Experimental group

Description:

Ropivacaine 5 mg/ml

Treatment:

Other: Triple inguinal nerve block.

Unilateral subarachnoid anesthesia

Active Comparator group

Description:

Bupivacaine 10 mg/ml

Treatment:

Other: Unilateral subarachnoid anesthesia