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Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

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ClinicalTrials.gov Identifier: NCT01986946
Recruitment Status : Terminated (Lack of recruitment.)
First Posted : November 19, 2013
Results First Posted : November 11, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 3, 2013
First Posted Date  ICMJE November 19, 2013
Results First Submitted Date  ICMJE September 23, 2016
Results First Posted Date  ICMJE November 11, 2016
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Post-operative Pain as Assessed by Visual Analogue Scale (VAS) [ Time Frame: Postoperative day 1 ]
The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Post-operative pain as assessed by Visual Analogue Scale [ Time Frame: Baseline ]
  • Post-operative pain as assessed by Visual Analogue Scale [ Time Frame: Postoperative day 1 ]
  • Post-operative pain as assessed by Visual Analogue Scale [ Time Frame: Postoperative day 2 ]
  • Post-operative pain as assessed by Visual Analogue Scale [ Time Frame: Postoperative day 3 ]
  • Post-operative pain as assessed by Visual Analogue Scale [ Time Frame: Postoperative week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • Patient Satisfaction With Perioperative Analgesia [ Time Frame: Post-operative Day 1 ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
  • Patient Satisfaction With Perioperative Analgesia [ Time Frame: 6-Week Follow up Visit ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
  • Patient Satisfaction With Overall Care [ Time Frame: 6-Week Follow up Visit ]
    Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
  • Number of Participants With Events of Special Interest [ Time Frame: Post-operative Day 30 ]
    Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
  • Number of Participants With Adverse Events Related to the Study [ Time Frame: 6-week Follow up Visit ]
    Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
  • Total Post-operative Opioid Consumption [ Time Frame: during hospitalization (approximately 3-8 days) ]
  • Number of Participants Experiencing Delirium [ Time Frame: Post-operative Day 1 ]
  • Number of Participants Experiencing Delirium [ Time Frame: Post-operative Day 2 ]
  • Number of Participants Experiencing Delirium [ Time Frame: Post-operative Day 3 ]
  • Number of Participants Readmitted to Hospital Within 30 Days of Surgery [ Time Frame: Post-operative Day 30 ]
  • Length of Hospital Stay [ Time Frame: during hospitalization (approximately 3-8 days) ]
  • Wound Infection Rates [ Time Frame: during hospitalization (approximately 3-8 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Assessing change in patient functional status with regards to depression, anxiety, and pain [ Time Frame: Patients will be assessed at baseline and at 6 week post-operative surgical follow-up visit utilizing a series of previously validated study forms detailed in description. ]
    Hospital Anxiety and Depression Score, McGill Short-Form Pain Questionnaire, Oswestry Disability Index, and Short Form-12.
  • Patient satisfaction with peri-operative care [ Time Frame: Recovery room - 6 hours post-operatively ]
    Patients will be assessed for satisfaction with their peri-operative care in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with peri-operative care [ Time Frame: Post-operative Day 1 ]
    Patients will be assessed for satisfaction with their peri-operative care in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with peri-operative care [ Time Frame: Post-operative Day 2 ]
    Patients will be assessed for satisfaction with their peri-operative care in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with peri-operative care [ Time Frame: Post-operative Day 3 ]
    Patients will be assessed for satisfaction with their peri-operative care in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with peri-operative care [ Time Frame: 6-Week Follow up Visit ]
    Patients will be assessed for satisfaction with their peri-operative care in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with perioperative analgesia [ Time Frame: Recovery Room - 6 hours after surgery ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient Satisfaction With Perioperative Analgesia [ Time Frame: Post-operative Day 1 ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with perioperative analgesia [ Time Frame: Post-operative Day 2 ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient satisfaction with perioperative analgesia [ Time Frame: Post-operative Day 3 ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Patient Satisfaction With Perioperative Analgesia [ Time Frame: 6-Week Follow up Visit ]
    Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
  • Number of participants with adverse events [ Time Frame: Receovery Room - 6 hours post-operatively ]
    Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
  • Number of participants with adverse events [ Time Frame: Post-operative Day 1 ]
    Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
  • Number of participants with adverse events [ Time Frame: Post-operative Day 2 ]
    Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
  • Number of participants with adverse events [ Time Frame: Post-operative Day 3 ]
    Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
  • Number of participants with adverse events [ Time Frame: 6-week Follow up Visit ]
    Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
Official Title  ICMJE A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
Brief Summary
  1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
  2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.

Hypothesis:

The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lumbar Spine Fusion
  • Pain
  • Back Pain
Intervention  ICMJE
  • Other: Epidural Catheter - Dilaudid
    Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
  • Drug: Dilaudid
    Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
Study Arms  ICMJE
  • Experimental: Intravenous opioids
    This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
    Intervention: Drug: Dilaudid
  • Experimental: Epidural Catheter
    The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
    Intervention: Other: Epidural Catheter - Dilaudid
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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
17
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2013)
200
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery

Exclusion Criteria:

  • Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
  • Inability to follow directions or comprehend the English language.
  • Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
  • Prisoners.
  • Patient refusal to provide informed consent.
  • Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986946
Other Study ID Numbers  ICMJE Pro00041252
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin L Manning, MD/PhD Duke University Hospital Department of Anesthesiology
Principal Investigator: Carlos Bagley, MD Duke University Hospital Department of Neurosurgery
PRS Account Duke University
Verification Date January 2017

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