The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

Sponsor

KBC Split (Other)

Overall Status

Completed

CT.gov ID

NCT05034406

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Varicocele Postoperative Pain	Drug: 2% Lidocaine Drug: 0.5% levobupivacaine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine group A total amount of 6 mL of 2% lidocaine was injected at the three trocar insertion sites (2 mL at each insertion site) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.	Drug: 2% Lidocaine 6 mL of 2% lidocaine injected at the trocar insertion site.
Experimental: Levobupivacaine Total amount of 6 mL of 0.5% levobupivacaine was injected at the three trocar insertion sites (2 mL at each) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.	Drug: 0.5% levobupivacaine 6 mL of 0.5% levobupivacaine injected at the trocar insertion site.
No Intervention: Control group No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure

Arm

Intervention/Treatment

Experimental: Lidocaine group

A total amount of 6 mL of 2% lidocaine was injected at the three trocar insertion sites (2 mL at each insertion site) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.

Drug: 2% Lidocaine

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

Experimental: Levobupivacaine

Total amount of 6 mL of 0.5% levobupivacaine was injected at the three trocar insertion sites (2 mL at each) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.

Drug: 0.5% levobupivacaine

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

No Intervention: Control group

No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure

Outcome Measures

Primary Outcome Measures

Pain (as measured by Visual analogue scale) [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 Outcome Measures

Pain (as measured by Visual analogue scale) [2 hours after surgery]
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
Pain (as measured by Visual analogue scale) [12 hours after surgery]
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
Pain (as measured by Visual analogue scale) [24 hours after surgery]
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Split	Split	Splitsko-dalmatinska	Croatia	21000

Sponsors and Collaborators

KBC Split

Investigators

Study Chair: Zenon Pogorelić, MD, PhD, University of Split, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Goran Tintor, Medical doctor, surgery resident, KBC Split

ClinicalTrials.gov Identifier:

NCT05034406

Other Study ID Numbers:

500-03/20-01/09

First Posted:

Sep 5, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021