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OpenTrials
Completed

NCT Number: NCT03968523

Loco/Regional Anaesthesia Evaluation in Laparoscopic Hernioplasty

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, 1181, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or more.
  • Programmed inguinal laparoscopic hernioplasty

Exclusion criteria

  • Allergic to medication prescribed
  • Story of mesh rejection

Treatment and study plan

Novel local infiltration technique

Procedure

Local analgesic infiltration in the mesh fixation site

TAP Block

Procedure

TAP block technique

Primary outcomes

  1. Postoperative pain

    Time frame: 30 days postoperative

    Postoperative main measured by an visual analogue scale

Secondary outcomes

  1. Analgesics consumption

    Time frame: 30 days postoperative

    Time to analgesic consumption

  2. type of analgesic consumption

    Time frame: 30 days

    type of analgesic consumption

  3. pain at the moment of need of analgesics take

    Time frame: 30 days

    pain measured at the analgesic consumption

Other outcomes

  1. Postoperative complications

    Time frame: 30 days postoperative

    Seroma, hematoma, surgical site infection

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 30, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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