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Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03968523
Enrollment
62
Registered
2019-05-30
Start date
2019-04-23
Completion date
2020-06-29
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Postoperative pain, Laparoscopic inguinal hernioplasty, TAP block

Brief summary

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.

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.

Interventions

PROCEDURENovel local infiltration technique

Local analgesic infiltration in the mesh fixation site

PROCEDURETAP block

TAP block technique

Sponsors

Hospital Italiano de Buenos Aires
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Each patient will be included in one cohort of treatment by a randomized criteria.

Intervention model description

Two randomized cohorts of treatment.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or more. * Programmed inguinal laparoscopic hernioplasty

Exclusion criteria

* Allergic to medication prescribed * Story of mesh rejection

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain30 days postoperativePostoperative main measured by an visual analogue scale

Secondary

MeasureTime frameDescription
Analgesics consumption30 days postoperativeTime to analgesic consumption
type of analgesic consumption30 daystype of analgesic consumption
pain at the moment of need of analgesics take30 dayspain measured at the analgesic consumption

Other

MeasureTime frameDescription
Postoperative complications30 days postoperativeSeroma, hematoma, surgical site infection

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026