The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Varicocele
• Intervention / Treatment: Drug: 2% Lidocaine; Drug: 0.5% levobupivacaine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Splitsko-dalmatinska
    • Split, Splitsko-dalmatinska, Croatia, 21000
      • University Hospital Split

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: KBC Split
• Investigators: Study Chair: Zenon Pogorelić, MD, PhD, University of Split, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Varicocele; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Levobupivacaine
• Other Study ID Numbers: 500-03/20-01/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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