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

Inguinal Hernia Clinical Trial

— U-IFB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521481
• Other study ID #: AR HSG 03 2010
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2012
• Last updated: February 3, 2014
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2014
• Source: Azienda Ospedaliera San Gerardo di Monza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Other:
• Triple inguinal nerve block.
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
• Unilateral subarachnoid anesthesia
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Supplemental local anesthesia infiltration	If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.	During surgery, up to 2 hours.	No
Secondary	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	No
Secondary	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	No
Secondary	Analgesic requirement	Assessed at every evaluation time postoperatively.	Up to 7 days	No
Secondary	Activity	Assessed through the activities assessment questionnaire 7 days after surgery.	Up to 7 days	No
Secondary	Adverse events.	Assessed at every evaluation time and including surgical and anesthesiological related events.	Up to 7 days	Yes
Secondary	Time from the end of anesthesia to first micturition.	Assessed at every evaluation time postoperatively.	Up to 24 hours.	No
Secondary	Time from the end of surgery to the first unassisted walking.	Assessed at every evaluation time postoperatively.	Up to 24 hours.	No
Secondary	Total intrahospital stay.	Assessed at every evaluation time postoperatively.	Up to 24 hours.	No