Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 87
- Locations
- 2
- Primary Endpoint
- Pain Intensity.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
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.)
Investigators
Zhirajr Mokini M.D.
Principal Investigator
Azienda Ospedaliera San Gerardo di Monza