Back to resultsLocal Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia
Primary Purpose
Inguinal Hernia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blind Local Anesthetic infiltration
Transversals Fascia Block
Spinal Anesthesia
Ropivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
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;
Sites / Locations
- ASST Cremona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Blind Local Anesthetic Infiltration
Transversals Fascia Block
Spinal Anesthesia
Arm Description
Outcomes
Primary Outcome Measures
Hospital discharge
Time need to reach hospital discharge criteria in post-operative period
Secondary Outcome Measures
Intraoperative Pain Control
Need of addiction local anesthetic or endovascular anesthetic to performed surgery
Post-operative Pain
NRS score in post-operative period
Side effects
Incidence of side effects
Chronic Pain
Incidence of chronic post-operative pain
Full Information
NCT ID
NCT03128216
First Posted
April 12, 2017
Last Updated
April 24, 2017
Sponsor
Istituti Ospitalieri di Cremona
1. Study Identification
Unique Protocol Identification Number
NCT03128216
Brief Title
Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia
Official Title
Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituti Ospitalieri di Cremona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blind Local Anesthetic Infiltration
Arm Type
Active Comparator
Arm Title
Transversals Fascia Block
Arm Type
Active Comparator
Arm Title
Spinal Anesthesia
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Blind Local Anesthetic infiltration
Intervention Description
Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.
Intervention Type
Procedure
Intervention Name(s)
Transversals Fascia Block
Intervention Description
Patients of this group received ultrasound guided omolateral Transversals Fascia Block.
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Patients of this group received Spinal Anesthesia
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Local anesthetic used for local infiltration and Transversals fascia block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Local anesthetic used for Spinal Anesthesia
Primary Outcome Measure Information:
Title
Hospital discharge
Description
Time need to reach hospital discharge criteria in post-operative period
Time Frame
First 6 post-operative hours
Secondary Outcome Measure Information:
Title
Intraoperative Pain Control
Description
Need of addiction local anesthetic or endovascular anesthetic to performed surgery
Time Frame
Intraoperative period
Title
Post-operative Pain
Description
NRS score in post-operative period
Time Frame
Post-operative period for 6 hours, every 30 min
Title
Side effects
Description
Incidence of side effects
Time Frame
intra-operative and post-operative period (6 hours)
Title
Chronic Pain
Description
Incidence of chronic post-operative pain
Time Frame
at 1 week and 3 months in post-operative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Basso Ricci, M.D.
Phone
+3903724050
Email
e.bassoricci@asst-cremona.it
Facility Information:
Facility Name
ASST Cremona
City
Creom
State/Province
Cremona
ZIP/Postal Code
26100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia
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