The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Varicocele, Postoperative Pain

Intervention / Treatment
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* Drug: 2% Lidocaine
* Drug: 0.5% levobupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>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<br>* 6 mL of 2% lidocaine injected at the trocar insertion site.<br>|
| Experimental: Levobupivacaine<br>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<br>* 6 mL of 0.5% levobupivacaine injected at the trocar insertion site.<br>|
| No Intervention: Control group<br>No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure | |

What is the study measuring?
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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 |