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

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

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).

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Other: Triple inguinal nerve block.; Other: Unilateral subarachnoid anesthesia

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 Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Monza, Italy, 20900
    • San Gerardo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triple inguinal nerve block; Ropivacaine 5 mg/ml	Other: Triple inguinal nerve block.; Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.; Other Names: Regional anesthesia for the groin.
Active Comparator: Unilateral subarachnoid anesthesia; Bupivacaine 10 mg/ml	Other: Unilateral subarachnoid anesthesia; Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.; Other Names: Regional anesthesia for the groin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplemental local anesthesia infiltration	If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.	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.	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.	Up to 24 hours
Analgesic requirement	Assessed at every evaluation time postoperatively.	Up to 7 days
Activity	Assessed through the activities assessment questionnaire 7 days after surgery.	Up to 7 days
Adverse events.	Assessed at every evaluation time and including surgical and anesthesiological related events.	Up to 7 days
Time from the end of anesthesia to first micturition.	Assessed at every evaluation time postoperatively.	Up to 24 hours.
Time from the end of surgery to the first unassisted walking.	Assessed at every evaluation time postoperatively.	Up to 24 hours.
Total intrahospital stay.	Assessed at every evaluation time postoperatively.	Up to 24 hours.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Gerardo di Monza
• Investigators: Principal Investigator: Zhirajr Mokini, M.D., San Gerardo Hospital; Study Director: Pablo Mauricio Ingelmo, M.D., San Gerardo Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: AR HSG 03 2010