An interventional study of 2% Lidocaine and 0.5% levobupivacaine in Varicocele and Postoperative Pain, sponsored by KBC Split. Completed at 1 site in Croatia. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by KBC Split · Not applicable, Interventional, and Treatment
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.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →KBC Split is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure
6 mL of 2% lidocaine injected at the trocar insertion site.
6 mL of 0.5% levobupivacaine injected at the trocar insertion site.
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.
Time frame: 6 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in May 2021, 24 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Levobupivacaine
KBC Split