NCT01521481

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

January 24, 2012

Last Update Submit

February 3, 2014

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Supplemental local anesthesia infiltration

    During surgery, up to 2 hours.

  • Conversion to general anesthesia.

    During surgery, up to 2 hours

  • mPADSS (Post-Anesthesia Discharge Scoring System)

    Up to 24 hours

  • Analgesic requirement

    Up to 7 days

  • Activity

    Up to 7 days

  • +4 more secondary outcomes

Study Arms (2)

Triple inguinal nerve block

EXPERIMENTAL

Ropivacaine 5 mg/ml

Other: Triple inguinal nerve block.

Unilateral subarachnoid anesthesia

ACTIVE COMPARATOR

Bupivacaine 10 mg/ml

Other: Unilateral subarachnoid anesthesia

Interventions

Triple inguinal nerve block.OTHER

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

Also known as: Regional anesthesia for the groin.
Triple inguinal nerve block
Unilateral subarachnoid anesthesiaOTHER

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

Also known as: Regional anesthesia for the groin.
Unilateral subarachnoid anesthesia

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Gerardo Hospital

Monza, 20900, Italy

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Zhirajr Mokini, M.D.

    San Gerardo Hospital

    PRINCIPAL INVESTIGATOR

  • Pablo Mauricio Ingelmo, M.D.

    San Gerardo Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 30, 2012

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

IT(1)