The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain

NCT05034406 | Completed

• 1 other identifier: 500-03/20-01/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicocele; Postoperative Pain

Outcome Measures

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.

  6 hours after surgery

Secondary Outcomes (3)

• Pain (as measured by Visual analogue scale)

  2 hours after surgery

• Pain (as measured by Visual analogue scale)

  12 hours after surgery

• Pain (as measured by Visual analogue scale)

  24 hours after surgery

Study Arms (3)

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.

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.

Drug: 0.5% levobupivacaine

Control group

NO INTERVENTION

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

Interventions

2% Lidocaine DRUG

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

Lidocaine group

0.5% levobupivacaine DRUG

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

Levobupivacaine

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KBC Split: lead

Study Sites (1)

University Hospital Split

Split, Split-Dalmatia County, 21000, Croatia

Location

MeSH Terms

Conditions

Varicocele; Pain, Postoperative

Interventions

Lidocaine; Levobupivacaine

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine

Study Officials

• Zenon Pogorelić, MD, PhD

  University of Split, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, surgery resident

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 5, 2021
• Study Start: May 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)