Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

April 24, 2017 updated by: Erika Basso Ricci, Istituti Ospitalieri di Cremona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Cremona
      • Creom, Cremona, Italy, 26100
        • ASST Cremona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blind Local Anesthetic Infiltration
Procedure: Blind Local Anesthetic infiltration
Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.
Drug: Ropivacaine
Local anesthetic used for local infiltration and Transversals fascia block
Active Comparator: Transversals Fascia Block
Drug: Ropivacaine
Local anesthetic used for local infiltration and Transversals fascia block
Procedure: Transversals Fascia Block
Patients of this group received ultrasound guided omolateral Transversals Fascia Block.
Active Comparator: Spinal Anesthesia
Procedure: Spinal Anesthesia
Patients of this group received Spinal Anesthesia
Drug: Bupivacaine
Local anesthetic used for Spinal Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital discharge
Time Frame: First 6 post-operative hours
Time need to reach hospital discharge criteria in post-operative period
First 6 post-operative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Pain Control
Time Frame: Intraoperative period
Need of addiction local anesthetic or endovascular anesthetic to performed surgery
Intraoperative period
Post-operative Pain
Time Frame: Post-operative period for 6 hours, every 30 min
NRS score in post-operative period
Post-operative period for 6 hours, every 30 min
Side effects
Time Frame: intra-operative and post-operative period (6 hours)
Incidence of side effects
intra-operative and post-operative period (6 hours)
Chronic Pain
Time Frame: at 1 week and 3 months in post-operative period
Incidence of chronic post-operative pain
at 1 week and 3 months in post-operative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Ospitalieri di Cremona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2017

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANECR_02_17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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