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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-02-29

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triple inguinal nerve block

Ropivacaine 5 mg/ml

Group Type EXPERIMENTAL

Triple inguinal nerve block.

Intervention Type OTHER

Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.

Unilateral subarachnoid anesthesia

Bupivacaine 10 mg/ml

Group Type ACTIVE_COMPARATOR

Unilateral subarachnoid anesthesia

Intervention Type OTHER

Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.

Interventions

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Triple inguinal nerve block.

Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.

Intervention Type OTHER

Unilateral subarachnoid anesthesia

Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.

Intervention Type OTHER

Other Intervention Names

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Regional anesthesia for the groin. Regional anesthesia for the groin.

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No