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Completed

NCT Number: NCT01521481

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

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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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

San Gerardo Hospital

Monza, 20900, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triple inguinal nerve block.

Other

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

Other names: Regional anesthesia for the groin.

Unilateral subarachnoid anesthesia

Other

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

Other names: Regional anesthesia for the groin.

Primary outcomes

  1. 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

  1. Supplemental local anesthesia infiltration

    Time frame: During surgery, up to 2 hours.

    If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.

  2. Conversion to general anesthesia.

    Time frame: During surgery, up to 2 hours

    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.

  3. mPADSS (Post-Anesthesia Discharge Scoring System)

    Time frame: Up to 24 hours

    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.

  4. Analgesic requirement

    Time frame: Up to 7 days

    Assessed at every evaluation time postoperatively.

  5. Activity

    Time frame: Up to 7 days

    Assessed through the activities assessment questionnaire 7 days after surgery.

  6. Adverse events.

    Time frame: Up to 7 days

    Assessed at every evaluation time and including surgical and anesthesiological related events.

  7. Time from the end of anesthesia to first micturition.

    Time frame: Up to 24 hours.

    Assessed at every evaluation time postoperatively.

  8. Time from the end of surgery to the first unassisted walking.

    Time frame: Up to 24 hours.

    Assessed at every evaluation time postoperatively.

  9. Total intrahospital stay.

    Time frame: Up to 24 hours.

    Assessed at every evaluation time postoperatively.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Other

Registry information

Official study title

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

Acronym: U-IFB

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 30, 2012
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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