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Clinical Trials/NCT03128216
NCT03128216
Unknown
N/A

Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair

Istituti Ospitalieri di Cremona1 site in 1 country48 target enrollmentApril 2017

Overview

Phase
N/A
Intervention
Blind Local Anesthetic infiltration
Conditions
Inguinal Hernia
Sponsor
Istituti Ospitalieri di Cremona
Enrollment
48
Locations
1
Primary Endpoint
Hospital discharge
Last Updated
9 years ago

Overview

Brief Summary

Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.

Registry
clinicaltrials.gov
Start Date
April 2017
End Date
September 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituti Ospitalieri di Cremona
Responsible Party
Principal Investigator
Principal Investigator

Erika Basso Ricci

Principal Investigator

Istituti Ospitalieri di Cremona

Eligibility Criteria

Inclusion Criteria

  • age\> 18 years;
  • ASA score I - II - III;
  • patients undergoing elective inguinal hernia repair;
  • signed informed consent;

Exclusion Criteria

  • chronic therapy with opioids/ antidepressants;
  • urgent/emergent surgery;
  • postoperative transfer to the intensive care unit;
  • known allergy to any drug medication;
  • local skin infection;
  • epilepsy;
  • alcohol or drug abuse;

Arms & Interventions

Blind Local Anesthetic Infiltration

Intervention: Blind Local Anesthetic infiltration

Blind Local Anesthetic Infiltration

Intervention: Ropivacaine

Transversals Fascia Block

Intervention: Transversals Fascia Block

Transversals Fascia Block

Intervention: Ropivacaine

Spinal Anesthesia

Intervention: Spinal Anesthesia

Spinal Anesthesia

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Hospital discharge

Time Frame: First 6 post-operative hours

Time need to reach hospital discharge criteria in post-operative period

Secondary Outcomes

  • Post-operative Pain(Post-operative period for 6 hours, every 30 min)
  • Intraoperative Pain Control(Intraoperative period)
  • Side effects(intra-operative and post-operative period (6 hours))
  • Chronic Pain(at 1 week and 3 months in post-operative period)

Study Sites (1)

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