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Post Operative Pain Control After Pediatric Hip Surgery

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ClinicalTrials.gov Identifier: NCT03435692
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Seattle Children's Research Institute Center for Clinical and Translational Research
Information provided by (Responsible Party):
David Liston, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE July 15, 2011
Actual Primary Completion Date July 29, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
Length of Stay [ Time Frame: Post operative days 0-2 ]
Hospital length of stay
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Post operative pain: ages 1-3 years [ Time Frame: Post operative day 0-2 ]
    The FLACC (Faces, Legs, Activity, Cry, Consolability) pain intensity rating scale was used to assess post operative pain by the patient's nurse in either the PACU or the floor. The FLACC is a validated behavior pain assessment scale for use in non-verbal patients unable to provide reports of pain. Each of the 5 assessments are given a score from 0-2 for a total pain scale range from 0 to 10.
  • Post operative pain: ages 3-7 years [ Time Frame: Post operative day 0-2 ]
    The Faces Pain Scale - Revised (FPS-R) was used to assess post operative pain by the patient's nurse in either the PACU or the floor. The Faces Pain Scale - Revised is a validated visual scale of 6 faces that represent different levels of pain (0,2,4,6,8,10). Patients were asked to point to the face that shows how much they hurt for a pain scale range from 0 to 10.
  • Post operative pain: ages 8 years and older [ Time Frame: Post operative day 0-2 ]
    Numeric Rating Scale was used to assess post operative pain by the patient's nurse in either the PACU or the floor. The Numeric Rating Scale is a validated self reported pain scale range from 0 to 10.
  • Opioid Consumption [ Time Frame: Post operative day 0-2 ]
    All administered opioids (measured as morphine equivalents / kg / day)
  • Side Effects [ Time Frame: Post operative day 0-2 ]
    Nausea, muscle spasm, pruritus
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Operative Pain Control After Pediatric Hip Surgery
Official Title  ICMJE Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
Brief Summary Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia with intravenous morphine (PCA).
Detailed Description

Approximately 1 in 1,000 children born in the US have hip dislocation and 10 in 1,000 have hip subluxation requiring surgical intervention. Pain after major hip surgery in children is severe, yet there is no agreement on the most effective method for pain control. Post-operative pain modalities including lumbar epidural catheters (LEC), lumbar plexus catheters (LPC) and intravenous patient controlled analgesia (IV-PCA) have been described. IV-PCA has historically been the standard of care in spite of its numerous associated side effects. Regional anesthesia modalities have gained popularity because of superior pain control with lower opioid requirements.

In this study, the investigators describe the first prospective randomized controlled trial comparing lumbar plexus catheter to alternatives for post-operative pain management in children after major hip surgery. The investigators hypothesized that LPC would be as safe and efficacious as LEC and IV-PCA with the added advantage of a decreased length of stay. The investigators primary aim was to compare hospital length of stay. Secondary aim was to compare pain scores, opioid consumption and opioid-related side effects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hip Surgery
  • Post Operative Pain Control
Intervention  ICMJE
  • Procedure: Lumbar Plexus Catheter
    lumbar plexus catheter placed intraoperatively for perioperative pain control
    Other Name: LPC
  • Procedure: Lumbar Epidural Catheter
    lumbar epidural catheter placed intraoperatively for perioperative pain control
    Other Name: LEC
  • Procedure: Patient Controlled Analgesia
    A PCA started post operatively for perioperative pain control
    Other Name: PCA
  • Drug: Fentanyl
    IV fentanyl was administered in the OR for induction of anesthesia. Subsequent doses in the OR were standardized to be given only for heart rate or blood pressure increases > 20% above baseline and occurring more than 30 minutes after the block (if applicable).
  • Drug: Morphine
    In the OR patients, IV morphine was administered if patients had a failed block and standardized to be given only for heart rate or blood pressure increases > 20% above baseline and after fentanyl had been administered. IV Morphine was also administered in the OR if the patient was randomized to the PCA arm of the study. Post operatively IV Morphine was administered as needed for severe pain.
  • Drug: Lorazepam
    IV Lorazepam was administered PRN for muscle spasm post operatively.
    Other Name: Ativan
  • Drug: Ondansetron
    IV Ondansetron was administered PRN for nausea and vomiting post operatively.
    Other Name: Zofran
  • Drug: Diphenhydramine
    IV Diphenhydramine was administered PRN for itching postoperatively.
    Other Name: Benadyrl
  • Drug: Acetaminophen
    PO Acetaminophen was administered PRN for pain in the PACU and then scheduled for 72 hours.
    Other Name: Tylenol
  • Drug: Oxycodone
    PO Oxycodone was administered PRN for breakthrough pain post operatively.
  • Drug: Ropivacaine
    IV Ropivacaine was administered as part of the initial bolus after placement of the lumbar epidural or lumbar plexus catheter and then as a continuous infusion post operatively.
Study Arms  ICMJE
  • Experimental: Lumbar Plexus Catheter

    Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.

    An intraoperative pain protocol will dictate if the patient will receive IV fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with PRN morphine and oxycodone as well as scheduled acetaminophen.

    Interventions:
    • Procedure: Lumbar Plexus Catheter
    • Drug: Fentanyl
    • Drug: Morphine
    • Drug: Lorazepam
    • Drug: Ondansetron
    • Drug: Diphenhydramine
    • Drug: Acetaminophen
    • Drug: Oxycodone
    • Drug: Ropivacaine
  • Active Comparator: Lumbar Epidural Catheter

    Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.

    An intraoperative pain protocol will dictate if the patient will receive IV fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with PRN morphine and oxycodone as well as scheduled acetaminophen.

    Interventions:
    • Procedure: Lumbar Epidural Catheter
    • Drug: Fentanyl
    • Drug: Morphine
    • Drug: Lorazepam
    • Drug: Ondansetron
    • Drug: Diphenhydramine
    • Drug: Acetaminophen
    • Drug: Oxycodone
    • Drug: Ropivacaine
  • Active Comparator: Patient Controlled Analgesia

    Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.

    An intraoperative pain protocol will dictate if the patient will receive IV fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with PRN morphine and oxycodone as well as scheduled acetaminophen.

    Interventions:
    • Procedure: Patient Controlled Analgesia
    • Drug: Fentanyl
    • Drug: Morphine
    • Drug: Lorazepam
    • Drug: Ondansetron
    • Drug: Diphenhydramine
    • Drug: Acetaminophen
    • Drug: Oxycodone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2018)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 29, 2014
Actual Primary Completion Date July 29, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children undergoing unilateral hip surgery, including pelvic innominate osteotomies, proximal femoral osteotomies, and arthrotomies (for open reduction, loose body removal, labral debridement or labral repair).

Exclusion Criteria:

  • history of a previous spine surgery, spina bifida, coagulopathy, skin infection, allergies to study medications (i.e. local anesthetics and opioids), patients taking opioids at the time of enrollment and, those having concurrent procedures distal to the hip
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435692
Other Study ID Numbers  ICMJE 13144
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Liston, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Seattle Children's Research Institute Center for Clinical and Translational Research
Investigators  ICMJE Not Provided
PRS Account Seattle Children's Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP