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Peripheral Nerve Blocks in Pediatric Orthopedic Patients

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ClinicalTrials.gov Identifier: NCT02236130
Recruitment Status : Terminated (Poor response rate on follow up of patients)
First Posted : September 10, 2014
Results First Posted : February 3, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Madhankumar Sathyamoorthy, University of Mississippi Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Pediatric Extremity Fracture Pediatric Extremity Soft Tissue Injury Procedure: Regional block Procedure: General Anesthesia Drug: Local Anesthetic Ropivacaine Drug: Opioids Morphine Drug: Oral pain medication Acetaminophen with Hydrocodone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Peripheral Nerve Blocks in Pediatric Orthopedic Patients: Are There Any Post Recovery Benefits?
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

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: 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




Primary Outcome Measures :
  1. Total Hydrocodone Dose (mg/kg) [ Time Frame: day 2 and day 8 after the surgery ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236130


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: madhankumar sathyamoorthy, MBBS, MS University of Mississippi Medical Center

Publications:

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Responsible Party: Madhankumar Sathyamoorthy, Assistant Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT02236130     History of Changes
Other Study ID Numbers: 2014-0027
First Posted: September 10, 2014    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 13, 2017
Last Verified: December 2016
Keywords provided by Madhankumar Sathyamoorthy, University of Mississippi Medical Center:
pediatric regional
Additional relevant MeSH terms:
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Soft Tissue Injuries
Wounds and Injuries
Acetaminophen
Morphine
Hydrocodone
Anesthetics
Ropivacaine
Anesthetics, Local
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Antitussive Agents
Respiratory System Agents