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The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

K

KBC Split

Status

Completed

Conditions

Postoperative Pain
Varicocele

Treatments

Drug: 0.5% levobupivacaine
Drug: 2% Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05034406
500-03/20-01/09

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Lidocaine group
Experimental group
Description:
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.
Treatment:
Drug: 2% Lidocaine
Levobupivacaine
Experimental group
Description:
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.
Treatment:
Drug: 0.5% levobupivacaine
Control group
No Intervention group
Description:
No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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