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Clinical Trials/NCT01521481
NCT01521481
Completed
Phase 4

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

Azienda Ospedaliera San Gerardo di Monza1 site in 1 country87 target enrollmentApril 2011
ConditionsInguinal Hernia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Azienda Ospedaliera San Gerardo di Monza
Enrollment
87
Locations
1
Primary Endpoint
Pain Intensity.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
February 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Azienda Ospedaliera San Gerardo di Monza
Responsible Party
Principal Investigator
Principal Investigator

Zhirajr Mokini M.D.

Principal Investigator

Azienda Ospedaliera San Gerardo di Monza

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

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

Outcomes

Primary Outcomes

Pain Intensity.

Time Frame: 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 Outcomes

  • Analgesic requirement(Up to 7 days)
  • Supplemental local anesthesia infiltration(During surgery, up to 2 hours.)
  • Conversion to general anesthesia.(During surgery, up to 2 hours)
  • Activity(Up to 7 days)
  • Adverse events.(Up to 7 days)
  • Time from the end of anesthesia to first micturition.(Up to 24 hours.)
  • Time from the end of surgery to the first unassisted walking.(Up to 24 hours.)
  • mPADSS (Post-Anesthesia Discharge Scoring System)(Up to 24 hours)
  • Total intrahospital stay.(Up to 24 hours.)

Study Sites (1)

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