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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Triple inguinal nerve block.
Unilateral subarachnoid anesthesia
Sponsored by
Azienda Ospedaliera San Gerardo di Monza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Gerardo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triple inguinal nerve block

Unilateral subarachnoid anesthesia

Arm Description

Ropivacaine 5 mg/ml

Bupivacaine 10 mg/ml

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Supplemental local anesthesia infiltration
If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
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.
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.
Analgesic requirement
Assessed at every evaluation time postoperatively.
Activity
Assessed through the activities assessment questionnaire 7 days after surgery.
Adverse events.
Assessed at every evaluation time and including surgical and anesthesiological related events.
Time from the end of anesthesia to first micturition.
Assessed at every evaluation time postoperatively.
Time from the end of surgery to the first unassisted walking.
Assessed at every evaluation time postoperatively.
Total intrahospital stay.
Assessed at every evaluation time postoperatively.

Full Information

First Posted
January 24, 2012
Last Updated
February 3, 2014
Sponsor
Azienda Ospedaliera San Gerardo di Monza
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1. Study Identification

Unique Protocol Identification Number
NCT01521481
Brief Title
Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery
Acronym
U-IFB
Official Title
Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera San Gerardo di Monza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triple inguinal nerve block
Arm Type
Experimental
Arm Description
Ropivacaine 5 mg/ml
Arm Title
Unilateral subarachnoid anesthesia
Arm Type
Active Comparator
Arm Description
Bupivacaine 10 mg/ml
Intervention Type
Other
Intervention Name(s)
Triple inguinal nerve block.
Other Intervention Name(s)
Regional anesthesia for the groin.
Intervention Description
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
Intervention Type
Other
Intervention Name(s)
Unilateral subarachnoid anesthesia
Other Intervention Name(s)
Regional anesthesia for the groin.
Intervention Description
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
Primary Outcome Measure Information:
Title
Pain Intensity.
Description
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).
Time Frame
Up to 24 hours.
Secondary Outcome Measure Information:
Title
Supplemental local anesthesia infiltration
Description
If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
Time Frame
During surgery, up to 2 hours.
Title
Conversion to general anesthesia.
Description
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.
Time Frame
During surgery, up to 2 hours
Title
mPADSS (Post-Anesthesia Discharge Scoring System)
Description
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.
Time Frame
Up to 24 hours
Title
Analgesic requirement
Description
Assessed at every evaluation time postoperatively.
Time Frame
Up to 7 days
Title
Activity
Description
Assessed through the activities assessment questionnaire 7 days after surgery.
Time Frame
Up to 7 days
Title
Adverse events.
Description
Assessed at every evaluation time and including surgical and anesthesiological related events.
Time Frame
Up to 7 days
Title
Time from the end of anesthesia to first micturition.
Description
Assessed at every evaluation time postoperatively.
Time Frame
Up to 24 hours.
Title
Time from the end of surgery to the first unassisted walking.
Description
Assessed at every evaluation time postoperatively.
Time Frame
Up to 24 hours.
Title
Total intrahospital stay.
Description
Assessed at every evaluation time postoperatively.
Time Frame
Up to 24 hours.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhirajr Mokini, M.D.
Organizational Affiliation
San Gerardo Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Mauricio Ingelmo, M.D.
Organizational Affiliation
San Gerardo Hospital
Official's Role
Study Director
Facility Information:
Facility Name
San Gerardo Hospital
City
Monza
ZIP/Postal Code
20900
Country
Italy

12. IPD Sharing Statement

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

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