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

Phase 4

Completed

• Conditions: Inguinal Hernia
• Interventions: Other: Unilateral subarachnoid anesthesia; Other: Triple inguinal nerve block.

• Registration Number: NCT01521481
• Lead Sponsor: Azienda Ospedaliera San Gerardo di Monza

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-10
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-30
• Study Completion: 2012-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral subarachnoid anesthesia	Unilateral subarachnoid anesthesia	Bupivacaine 10 mg/ml
Triple inguinal nerve block	Triple inguinal nerve block.	Ropivacaine 5 mg/ml

Primary Outcome Measures

Name	Time	Method
Pain Intensity.	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).

Secondary Outcome Measures

Name	Time	Method
Analgesic requirement	Up to 7 days	Assessed at every evaluation time postoperatively.
Supplemental local anesthesia infiltration	During surgery, up to 2 hours.	If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
Conversion to general anesthesia.	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.
Activity	Up to 7 days	Assessed through the activities assessment questionnaire 7 days after surgery.
Adverse events.	Up to 7 days	Assessed at every evaluation time and including surgical and anesthesiological related events.
Time from the end of anesthesia to first micturition.	Up to 24 hours.	Assessed at every evaluation time postoperatively.
Time from the end of surgery to the first unassisted walking.	Up to 24 hours.	Assessed at every evaluation time postoperatively.
mPADSS (Post-Anesthesia Discharge Scoring System)	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.
Total intrahospital stay.	Up to 24 hours.	Assessed at every evaluation time postoperatively.

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, Italy