TAP Block With Two Different Doses of Levobupivacaine

Pain, Postoperative Clinical Trial

Official title:

Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02567487
• Other study ID #: 931893045140401
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 17, 2015
• Last updated: October 2, 2015
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2015
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery.

The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.

Description:

Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia

• Aged between 2 and 12

Exclusion Criteria:

• Patients with coagulation dysfunction

• Patients with chronic pain

• Patients having infection at the site of intervention

• Patients with a history of allergy

• Patients having chronic diseases (hepatic dysfunction, renal failure)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Levobupivacaine
Transversus abdominis plane block with levobupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative VAS score <4 at postoperative 24 hours		Postoperative first 24 hours	Yes