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TAP Block With Two Different Doses of Levobupivacaine

A

Ankara University

Status and phase

Unknown
Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02567487
931893045140401

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Group Levobupivacaine high volume
Active Comparator group
Description:
TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia
Treatment:
Drug: Levobupivacaine
Group Levobupivacaine low volume
Active Comparator group
Description:
TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia
Treatment:
Drug: Levobupivacaine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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