The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034406
• Other study ID #: 500-03/20-01/09
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: KBC Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Varicocele

Intervention

Drug:
• 2% Lidocaine
6 mL of 2% lidocaine injected at the trocar insertion site.
• 0.5% levobupivacaine
6 mL of 0.5% levobupivacaine injected at the trocar insertion site.

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split	Splitsko-dalmatinska

Sponsors (1)

Lead Sponsor	Collaborator
KBC Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (as measured by Visual analogue scale)	Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.	6 hours after surgery
Secondary	Pain (as measured by Visual analogue scale)	Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.	2 hours after surgery
Secondary	Pain (as measured by Visual analogue scale)	Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.	12 hours after surgery
Secondary	Pain (as measured by Visual analogue scale)	Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.	24 hours after surgery