CClinicalTrials.gg
CompletedNCT05034406Updated Sep 5, 2021

The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Varicocele
  • Postoperative Pain
03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • pediatric patients with varicocele who underwent laparoscopic varicocelectomy
  • pediatric patients whose parents or guardians gave informed consent

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Lidocaine group

    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

  • Experimental
    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.

    Drug: 0.5% levobupivacaine

  • No intervention
    Control group

    No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure

Interventions

  • Drug2% Lidocaine

    6 mL of 2% lidocaine injected at the trocar insertion site.

  • Drug0.5% levobupivacaine

    6 mL of 0.5% levobupivacaine injected at the trocar insertion site.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  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.

    Time frame: 24 hours after surgery

06

Study locations

1 site
  • University Hospital Split
    Split, Splitsko-dalmatinska 21000, Croatia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05034406
Lead sponsor
KBC Split
Responsible party
Goran Tintor (Medical doctor, surgery resident, KBC Split) — Principal investigator
First posted
Sep 5, 2021
Start date
May 1, 2019
Primary completion
May 31, 2021
Completion
May 31, 2021
Last update
Sep 5, 2021

Study contacts

Zenon Pogorelić, MD, PhD
study chair · University of Split, School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion