Skip to main content
OpenTrials
Completed

NCT Number: NCT05034406

The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

Aim of this study is to examine the effects of subcutaneously applied local anesthetics at trocar site in combination with intraoperative intraperitoneal analgesia on duration and character of pain in pediatric patients undergoing laparoscopic varicocelectomy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicocele Cardiovascular Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Urogenital Diseases Vascular Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Split

Split, Split-Dalmatia County, 21000, Croatia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pediatric patients with varicocele who underwent laparoscopic varicocelectomy
  • pediatric patients whose parents or guardians gave informed consent

Exclusion criteria

  • patients who received open or microsurgical varicocelectomy
  • pediatric patients who underwent conversion to open procedure
  • pediatric patients with chronic, metabolic and endocrine diseases
  • pediatric patients with systemic infections

Treatment and study plan

2% lidocaine

Drug

6 mL of 2% lidocaine injected at the trocar insertion site.

0.5% Levobupivacaine

Drug

6 mL of 0.5% levobupivacaine injected at the trocar insertion site.

Primary outcomes

  1. Pain (as measured by Visual analogue scale)

    Time frame: 6 hours after surgery

    Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.

Secondary outcomes

  1. Pain (as measured by Visual analogue scale)

    Time frame: 2 hours after surgery

    Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.

  2. Pain (as measured by Visual analogue scale)

    Time frame: 12 hours after surgery

    Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.

  3. Pain (as measured by Visual analogue scale)

    Time frame: 24 hours after surgery

    Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.

Sponsors and collaborators

Lead sponsor

KBC Split

Other

Registry information

Official study title

The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain After Laparoscopic Varicocelectomy: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Sep 5, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.