The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

NCT ID: NCT05034406

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Varicocele Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

2% Lidocaine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

0.5% levobupivacaine

Intervention Type DRUG

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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2% Lidocaine

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

Intervention Type DRUG

0.5% levobupivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KBC Split

OTHER

Sponsor Role lead

Responsible Party

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Goran Tintor

Medical doctor, surgery resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zenon Pogorelić, MD, PhD

Role: STUDY_CHAIR

University of Split, School of Medicine

Locations

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University Hospital Split

Split, Split-Dalmatia County, Croatia

Site Status

Countries

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Croatia

Other Identifiers

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500-03/20-01/09

Identifier Type: -

Identifier Source: org_study_id

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