NCT02236130

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 3, 2016

Completed
Last Updated

February 13, 2017

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

August 25, 2014

Results QC Date

December 30, 2015

Last Update Submit

December 22, 2016

Conditions

Pediatric Extremity FracturePediatric Extremity Soft Tissue Injury

Keywords

pediatric regional

Outcome Measures

Primary Outcomes (1)

  • Total Hydrocodone Dose (mg/kg)

    day 2 and day 8 after the surgery

Secondary Outcomes (1)

  • Patient/Family Satisfaction With Pain Management

    one week after the surgery

Study Arms (2)

General

ACTIVE COMPARATOR

General Anesthesia only

Procedure: General AnesthesiaDrug: Opioids MorphineDrug: Oral pain medication Acetaminophen with Hydrocodone

Regional

EXPERIMENTAL

General Anesthesia combined with regional block

Procedure: Regional blockProcedure: General AnesthesiaDrug: Local Anesthetic RopivacaineDrug: Opioids MorphineDrug: Oral pain medication Acetaminophen with Hydrocodone

Interventions

Regional blockPROCEDURE

Single shot peripheral nerve block

Regional
General AnesthesiaPROCEDURE

General Anesthesia with O2/N2O/Sevoflurane

GeneralRegional
Local Anesthetic RopivacaineDRUG

0.5% Ropivacaine

Regional
Opioids MorphineDRUG

Morphine

GeneralRegional
Oral pain medication Acetaminophen with HydrocodoneDRUG

Acetaminophen with Hydrocodone

GeneralRegional

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (7)

  • Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.

    PMID: 22786464BACKGROUND

  • Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21.

    PMID: 18498436BACKGROUND

  • Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.

    PMID: 24330523BACKGROUND

  • Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.

    PMID: 24407716BACKGROUND

  • Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.

    PMID: 21895855BACKGROUND

  • Polaner DM, Martin LD; PRAN Investigators. Quality assurance and improvement: the Pediatric Regional Anesthesia Network. Paediatr Anaesth. 2012 Jan;22(1):115-9. doi: 10.1111/j.1460-9592.2011.03708.x. Epub 2011 Sep 27.

    PMID: 21951324BACKGROUND

  • Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.

    PMID: 21199114BACKGROUND

MeSH Terms

Interventions

Anesthesia, GeneralHydrocodone

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Madhankumar Sathyamoorthy
Organization
University of Mississippi Medical Center
msathyamoorthy@umc.edu
6018157066

Study Officials

  • madhankumar sathyamoorthy, MBBS, MS

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 10, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

February 13, 2017

Results First Posted

February 3, 2016

Record last verified: 2016-12

Locations

US(1)