Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

NCT ID: NCT03128216

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Blind Local Anesthetic Infiltration

Group Type ACTIVE_COMPARATOR

Blind Local Anesthetic infiltration

Intervention Type PROCEDURE

Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.

Ropivacaine

Intervention Type DRUG

Local anesthetic used for local infiltration and Transversals fascia block

Transversals Fascia Block

Group Type ACTIVE_COMPARATOR

Transversals Fascia Block

Intervention Type PROCEDURE

Patients of this group received ultrasound guided omolateral Transversals Fascia Block.

Ropivacaine

Intervention Type DRUG

Local anesthetic used for local infiltration and Transversals fascia block

Spinal Anesthesia

Group Type ACTIVE_COMPARATOR

Spinal Anesthesia

Intervention Type PROCEDURE

Patients of this group received Spinal Anesthesia

Bupivacaine

Intervention Type DRUG

Local anesthetic used for Spinal Anesthesia

Interventions

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Blind Local Anesthetic infiltration

Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.

Intervention Type PROCEDURE

Transversals Fascia Block

Patients of this group received ultrasound guided omolateral Transversals Fascia Block.

Intervention Type PROCEDURE

Spinal Anesthesia

Patients of this group received Spinal Anesthesia

Intervention Type PROCEDURE

Ropivacaine

Local anesthetic used for local infiltration and Transversals fascia block

Intervention Type DRUG

Bupivacaine

Local anesthetic used for Spinal Anesthesia

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituti Ospitalieri di Cremona

OTHER

Sponsor Role lead

Responsible Party

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Erika Basso Ricci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ASST Cremona

Creom, Cremona, Italy

Site Status

Countries

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Italy

Central Contacts

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Erika Basso Ricci, M.D.

Role: CONTACT

+3903724050

Other Identifiers

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ANECR_02_17

Identifier Type: -

Identifier Source: org_study_id

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