Back to resultsThe Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain
Primary Purpose
Varicocele, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
2% Lidocaine
0.5% levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Varicocele
Eligibility Criteria
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
Sites / Locations
- University Hospital Split
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Lidocaine group
Levobupivacaine
Control group
Arm Description
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.
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.
No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05034406
Brief Title
The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain
Official Title
The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain After Laparoscopic Varicocelectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KBC Split
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Levobupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure
Intervention Type
Drug
Intervention Name(s)
2% Lidocaine
Intervention Description
6 mL of 2% lidocaine injected at the trocar insertion site.
Intervention Type
Drug
Intervention Name(s)
0.5% levobupivacaine
Intervention Description
6 mL of 0.5% levobupivacaine injected at the trocar insertion site.
Primary Outcome Measure Information:
Title
Pain (as measured by Visual analogue scale)
Description
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
Time Frame
6 hours after surgery
Secondary Outcome Measure Information:
Title
Pain (as measured by Visual analogue scale)
Description
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
Time Frame
2 hours after surgery
Title
Pain (as measured by Visual analogue scale)
Description
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
Time Frame
12 hours after surgery
Title
Pain (as measured by Visual analogue scale)
Description
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zenon Pogorelić, MD, PhD
Organizational Affiliation
University of Split, School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Split
City
Split
State/Province
Splitsko-dalmatinska
ZIP/Postal Code
21000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain
We'll reach out to this number within 24 hrs