The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

Not Applicable

Completed

• Conditions: Varicocele; Postoperative Pain
• Interventions: Drug: 2% Lidocaine; Drug: 0.5% levobupivacaine

• Registration Number: NCT05034406
• Lead Sponsor: KBC Split

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Study First Submitted: 2021-08-09
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	2% Lidocaine	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.
Levobupivacaine	0.5% 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Split; 🇭🇷 Split, Splitsko-dalmatinska, Croatia