VaricoceleNCT05034406
The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain
A study testing 2% Lidocaine and 0.5% levobupivacaine in people with Varicocele and Postoperative Pain, run by KBC Split at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Varicocele, Postoperative Pain
- What is being tested?
- 2% Lidocaine and 0.5% levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 1 May 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patients with varicocele who underwent laparoscopic varicocelectomy
- pediatric patients whose parents or guardians gave informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Varicocele, Postoperative Pain
- Being tested
- 2% Lidocaine, 0.5% levobupivacaine
- Medical subject headings
- Varicocele, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% LidocaineDrug
6 mL of 2% lidocaine injected at the trocar insertion site.
0.5% levobupivacaineDrug
6 mL of 0.5% levobupivacaine injected at the trocar insertion site.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 2% Lidocaine |
| 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. Receives: Drug: 0.5% levobupivacaine |
| Control group | No intervention | No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 May 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBC Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Tintor, KBC Split
- Investigators
- Zenon Pogorelić, MD, PhD, Study chair, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034406
- Sponsor's protocol ID
- 500-03/20-01/09
- Status last verified
- Sep 2021
- First submitted
- 9 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain After Laparoscopic Varicocelectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05034406
- Acronym / sponsor ID
- 500-03/20-01/09
- Conditions
- Varicocele, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KBC SplitUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: 2% LidocaineA 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 | Drug: 0.5% levobupivacaineTotal 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pediatric patients with varicocele who underwent laparoscopic varicocelectomy
- pediatric patients whose parents or guardians gave informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Lidocaine6 mL of 2% lidocaine injected at the trocar insertion site. | Drug | Lidocaine group |
| 0.5% levobupivacaine6 mL of 0.5% levobupivacaine injected at the trocar insertion site. | Drug | Levobupivacaine |
Primary outcome
Pain (as measured by Visual analogue scale)
Time frame: 6 hours after surgery
Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.
3 secondary outcomes
Pain (as measured by Visual analogue scale)
Time frame: 2 hours after surgery
Pain (as measured by Visual analogue scale)
Time frame: 12 hours after surgery
Pain (as measured by Visual analogue scale)
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zenon Pogorelić, MD, PhD study chair
University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Lidocaine and 0.5% levobupivacaine in people with Varicocele and Postoperative Pain, run by KBC Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (as measured by Visual analogue scale) (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.