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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhirajr Mokini M.D., Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:
NCT01521481
First received: January 24, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Inguinal Hernia
Other: Triple inguinal nerve block.
Other: Unilateral subarachnoid anesthesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Gerardo di Monza:

Primary Outcome Measures:
  • Pain Intensity. [ Time Frame: Up to 24 hours. ] [ Designated as safety issue: No ]
    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 [ Time Frame: During surgery, up to 2 hours. ] [ Designated as safety issue: No ]
    If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.

  • Conversion to general anesthesia. [ Time Frame: During surgery, up to 2 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Assessed at every evaluation time postoperatively.

  • Activity [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Assessed through the activities assessment questionnaire 7 days after surgery.

  • Adverse events. [ Time Frame: Up to 7 days ] [ Designated as safety issue: Yes ]
    Assessed at every evaluation time and including surgical and anesthesiological related events.

  • Time from the end of anesthesia to first micturition. [ Time Frame: Up to 24 hours. ] [ Designated as safety issue: No ]
    Assessed at every evaluation time postoperatively.

  • Time from the end of surgery to the first unassisted walking. [ Time Frame: Up to 24 hours. ] [ Designated as safety issue: No ]
    Assessed at every evaluation time postoperatively.

  • Total intrahospital stay. [ Time Frame: Up to 24 hours. ] [ Designated as safety issue: No ]
    Assessed at every evaluation time postoperatively.


Enrollment: 87
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple inguinal nerve block
Ropivacaine 5 mg/ml
Other: Triple inguinal nerve block.
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
Other Name: Regional anesthesia for the groin.
Active Comparator: Unilateral subarachnoid anesthesia
Bupivacaine 10 mg/ml
Other: Unilateral subarachnoid anesthesia
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
Other Name: Regional anesthesia for the groin.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521481

Locations
Italy
San Gerardo Hospital
Monza, Italy, 20900
Sponsors and Collaborators
Azienda Ospedaliera San Gerardo di Monza
Investigators
Principal Investigator: Zhirajr Mokini, M.D. San Gerardo Hospital
Study Director: Pablo Mauricio Ingelmo, M.D. San Gerardo Hospital
  More Information

No publications provided

Responsible Party: Zhirajr Mokini M.D., Principal Investigator, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT01521481     History of Changes
Other Study ID Numbers: AR HSG 03 2010
Study First Received: January 24, 2012
Last Updated: February 3, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014