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analgesic effectiveness of ultrasound-guided ilioinguinal iliohypogastric after inguinal herniorrhaphy

analgesic effectiveness of ultrasound-guided ilioinguinal iliohypogastric and genitofemoral nerve block after inguinal herniorrhaphy - AR HSG 03 2010

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021851-23-IT
Enrollment
Unknown
Registered
2012-04-10
Start date
2011-04-19
Completion date
Unknown
Last updated
2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal hernia elective surgery MedDRA version: 14.1 Level: LLT Classification code 10019917 Term: Hernia inguinal System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacaine Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10- Pharmaceutical Form: Solution for injection IN

Sponsors

AZIENDA OSPEDALIERA S. GERARDO DI MONZA
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 18-90 years old Males; BMI =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: under 18 or over 90 years old; ASA IV- V ; emergency/urgency surgery; non type I-II-IV-V AHS/I-II-EHS direct or indirect or recurrent inguinal hernia; allergy to one of the drugs under investigation; analgesic drug administration before surgery; contraindication to unilateral subarachnoid blockade; no written informed consent.

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine if ultrasound-guided ilioinguinal iliohypogastric and genitofemoral nerve block with subcutaneous infiltration of Ropivacaine 5 mg/ml is more effective in the management of postoperative pain than unilateral subarachnoid blockade with hyperbaric bupivacaine 10 mg/ml;Secondary Objective: Need for supplemental local anesthesia, Need for intraoperative sedation; postoperative analgesic request; discharge criteria; time of post-operative voiding and time of unassisted walking; daily activities, pain and analgesic drugs administration during the 1st week; incidence of adverse events;Primary end point(s): Determine if ultrasound-guided ilioinguinal iliohypogastric and genitofemoral nerve block with subcutaneous infiltration of Ropivacaine 5 mg/ml is more effective in management of postoperative pain than unilateral subarachnoid blockade with hyperbaric bupivacaine 10 mg/ml;Timepoint(s) of evaluation of this end point: 24 h—

Secondary

MeasureTime frame
Secondary end point(s): Activity scale;Timepoint(s) of evaluation of this end point: 7 days—

Countries

Italy

Contacts

Public ContactSperimentatore principale

AO San Gerardo di Monza

zheri@hotmail.com0392339269

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026