Peripheral Nerve Blocks in Pediatric Orthopedic Patients

December 22, 2016 updated by: Madhankumar Sathyamoorthy, University of Mississippi Medical Center

Peripheral Nerve Blocks in Pediatric Orthopedic Patients: Are There Any Post Recovery Benefits?

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

80 children between the ages of 6yr and 17 yrs. scheduled for ambulatory peripheral orthopedic procedures in the operating rooms of Batson Children's Hospital will be enrolled in the study. Written informed consent will be obtained from the parents or legal guardian and assent will be obtained from patients when possible.

Once enrolled in the study, patients will be randomly assigned to one of two groups General anesthesia only (GA group) and General Anesthesia combined with regional anesthesia (RA group). Once the patients are brought to the operating room standard ASA monitors will be applied. After mask induction with O2/Nitrous oxide(N2O)/Sevoflurane(Sevo), a peripheral intravenous line will be inserted and secured. Additional IV medication propofol 2-3mg/kg will be given prior to insertion of appropriate size laryngeal mask airway (LMA). Patients in GA group will undergo the procedure under general anesthesia with Sevo/O2. Patients in the RA group will receive a peripheral nerve block appropriate for the procedure after induction of general anesthesia with O2/N2O/Sevo. The attending anesthesiologists will perform the nerve block under ultrasound guidance (Sonosite machine with high frequency probe) using 22G stimulating needle under aseptic precautions. 0.5% ropivacaine up to a total dose of 3mg/kg will be used for the block.

Anesthesia is maintained in both groups with O2/Sevo titrated to minimum alveolar concentration (MAC of) 1.5 . After surgical incision, doses of 0.05mg/kg morphine is given IV every 5 min as needed titrated to HR and BP within 10% change from baseline.

Additional IV morphine at the dose of 0.05mg/kg will be given every 10 minutes in the recovery room (PACU) as needed for pain ( Visual Analog score -VAS score >4). Total morphine consumption, length of recovery room stay and side effects such as nausea or vomiting will be recorded in the PACU.

The patients in the study will be given the following

  1. A prescription for oral analgesics (lortab: hydrocodone 5mg with acetaminophen 325mg).
  2. A handout about the nerve block and post op care (for patients in RA group)
  3. A handout depicting the visual analog scale
  4. Data sheet with date, time, pain scale and pain meds , satisfaction scale, documentation of side effects along with a stamped return envelope.

The parents will be educated about assessing pain and visual analog scale score. The parents will be instructed to give one or two pills depending on the weight (one pill for weight <50kg and 2 pills for weight >50kg)every 4-6 hrs. as needed for pain (VAS score more than 2).

The patients will be followed by phone by research nurse blinded to the group on postoperative day 2 and day 8. They will be asked about the total use of analgesics at the end of day 2 (first 48hrs) and day 7. Family satisfaction on a scale of 1 to10, Incidence of other side effects such as nausea, vomiting, sleep disturbance, feeding difficulty and prolonged numbness or motor block will also be collected.

The parents will also be requested to return the data sheet in the stamped return envelope to the research team.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General
General Anesthesia only
Procedure: General Anesthesia
General Anesthesia with O2/N2O/Sevoflurane
Drug: Opioids Morphine
Morphine
Drug: Oral pain medication Acetaminophen with Hydrocodone
Acetaminophen with Hydrocodone
Experimental: Regional
General Anesthesia combined with regional block
Procedure: General Anesthesia
General Anesthesia with O2/N2O/Sevoflurane
Drug: Opioids Morphine
Morphine
Drug: Oral pain medication Acetaminophen with Hydrocodone
Acetaminophen with Hydrocodone
Procedure: Regional block
Single shot peripheral nerve block
Drug: Local Anesthetic Ropivacaine
0.5% Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Hydrocodone Dose (mg/kg)
Time Frame: day 2 and day 8 after the surgery
day 2 and day 8 after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient/Family Satisfaction With Pain Management
Time Frame: one week after the surgery
Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.
one week after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: madhankumar sathyamoorthy, MBBS, MS, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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