Loco/Regional Anaesthesia Evaluation in Laparoscopic Hern... | NCT03968523

Studies
Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

NCT03968523

Sponsor

Hospital Italiano de Buenos Aires

Status

Completed

Last Update Posted

Jul 14, 2020Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Novel local infiltration technique
TAP block

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2019Actual

Primary Completion Date

Jun 29, 2020Actual

Completion Date

Jun 29, 2020Actual

First Submitted Date

May 20, 2019

First Submission Date that Met QC Criteria

May 27, 2019

First Posted Date

May 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2020

Last Update Posted Date

Jul 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. TAP block is the gold standard technique in this type of hernioplasty. Our aim is to compare TAP block with a novel local infiltration technique that uses direct laparoscopical vision. Patients will be randomized into two arms of intervention that will be compared by a blind analysis. Primary outcomes will be postoperative pain evaluated systematically until 30 days postoperative, and analgesic consumption.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP block	Active Comparator	TAP block technique.	Procedure: TAP block
Novel local infiltration technique	Experimental	Local analgesic infiltration in the mesh fixation site	Procedure: Novel local infiltration technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novel local infiltration technique	Procedure	Local analgesic infiltration in the mesh fixation site	Novel local infiltration technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain	Postoperative main measured by an visual analogue scale	30 days postoperative

Secondary Outcomes

Measure	Description	Time Frame
Analgesics consumption	Time to analgesic consumption	30 days postoperative
type of analgesic consumption	type of analgesic consumption

Other Outcomes

Measure	Description	Time Frame
Postoperative complications	Seroma, hematoma, surgical site infection	30 days postoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or more.
Programmed inguinal laparoscopic hernioplasty

Exclusion Criteria:

Allergic to medication prescribed
Story of mesh rejection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Santiago Bertone, MD	Surgeon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Italiano de Buenos Aires		Buenos Aires		1181	Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9164809	Background	Liem MS, van der Graaf Y, van Steensel CJ, Boelhouwer RU, Clevers GJ, Meijer WS, Stassen LP, Vente JP, Weidema WF, Schrijvers AJ, van Vroonhoven TJ. Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. N Engl J Med. 1997 May 29;336(22):1541-7. doi: 10.1056/NEJM199705293362201.
15515112

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain