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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine group | Experimental | 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 | Experimental | 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. |
|
| Control group | No Intervention | No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Lidocaine | Drug | 6 mL of 2% lidocaine injected at the trocar insertion site. |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zenon Pogorelić, MD, PhD | University of Split, School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Split | Split | Split-Dalmatia County | 21000 | Croatia |
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| ID | Term |
|---|---|
| D014646 | Varicocele |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 0.5% levobupivacaine |
| Drug |
6 mL of 0.5% levobupivacaine injected at the trocar insertion site. |
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002045 | Bupivacaine |