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Peripheral Nerve Blocks in Pediatric Orthopedic Patients

NCT02236130 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-02-13

Study results available
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Summary

Context:

Single shot peripheral nerve blocks have limited duration of action depending on the local anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need oral analgesics at home once the block wears off to control the pain.

Objectives:

Primary Objective

To determine if peripheral nerve blocks have any advantage in terms of decreasing oral analgesic requirements in the post operative period even after the effects of the block have worn off

Secondary Objective

To determine if inclusion of single shot regional technique improves patient/family satisfaction with post operative pain management .

Study Design:

Prospective randomized single blinded study.

Inclusion Criteria

* Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic surgery with moderate to severe postoperative pain.
* Surgery of moderate duration (\<2hr)
* Surgery associated with minimal blood loss or fluid shifts (\<10% total blood volume)
* American Society of Anesthesiologists (ASA) classification 1 or 2
* Parents able to understand follow up instructions and are able to reach at home by phone

Exclusion Criteria

* Known allergy to local anesthetics
* Preexisting neuropathy with sensory or motor deficits
* Skin infection at site of needle placement
* Parents refusal for peripheral nerve blocks

Conditions

  • Pediatric Extremity Fracture
  • Pediatric Extremity Soft Tissue Injury

Interventions

PROCEDURE

Regional block

Single shot peripheral nerve block

PROCEDURE

General Anesthesia

General Anesthesia with O2/N2O/Sevoflurane

DRUG

Local Anesthetic Ropivacaine

0.5% Ropivacaine

DRUG

Opioids Morphine

Morphine

DRUG

Oral pain medication Acetaminophen with Hydrocodone

Acetaminophen with Hydrocodone

Sponsors & Collaborators

  • University of Mississippi Medical Center

    lead OTHER

Principal Investigators

  • madhankumar sathyamoorthy, MBBS, MS · University of Mississippi Medical Center

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02236130 on ClinicalTrials.gov