NCT03128216

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

April 12, 2017

Last Update Submit

April 24, 2017

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Hospital discharge

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

    First 6 post-operative hours

Secondary Outcomes (4)

  • Intraoperative Pain Control

    Intraoperative period

  • Post-operative Pain

    Post-operative period for 6 hours, every 30 min

  • Side effects

    intra-operative and post-operative period (6 hours)

  • Chronic Pain

    at 1 week and 3 months in post-operative period

Study Arms (3)

Blind Local Anesthetic Infiltration

ACTIVE COMPARATOR
Procedure: Blind Local Anesthetic infiltrationDrug: Ropivacaine

Transversals Fascia Block

ACTIVE COMPARATOR
Procedure: Transversals Fascia BlockDrug: Ropivacaine

Spinal Anesthesia

ACTIVE COMPARATOR
Procedure: Spinal AnesthesiaDrug: Bupivacaine

Interventions

Blind Local Anesthetic infiltrationPROCEDURE

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

Blind Local Anesthetic Infiltration
Transversals Fascia BlockPROCEDURE

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

Transversals Fascia Block
Spinal AnesthesiaPROCEDURE

Patients of this group received Spinal Anesthesia

Spinal Anesthesia
RopivacaineDRUG

Local anesthetic used for local infiltration and Transversals fascia block

Blind Local Anesthetic InfiltrationTransversals Fascia Block
BupivacaineDRUG

Local anesthetic used for Spinal Anesthesia

Spinal Anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Cremona

Creom, Cremona, 26100, Italy

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthesia, SpinalRopivacaineBupivacaine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Erika Basso Ricci, M.D.

CONTACT

+3903724050e.bassoricci@asst-cremona.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 25, 2017

Study Start

April 1, 2017

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)