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Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Lumbar Spine Fusion Pain Back Pain Other: Epidural Catheter - Dilaudid Drug: Dilaudid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Dilaudid
Patients in this arm will receive intravenous patient-controlled opioid analgesia (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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. Total Post-operative Opioid Consumption [ Time Frame: during hospitalization (approximately 3-8 days) ]
  7. Number of Participants Experiencing Delirium [ Time Frame: Post-operative Day 1 ]
  8. Number of Participants Experiencing Delirium [ Time Frame: Post-operative Day 2 ]
  9. Number of Participants Experiencing Delirium [ Time Frame: Post-operative Day 3 ]
  10. Number of Participants Readmitted to Hospital Within 30 Days of Surgery [ Time Frame: Post-operative Day 30 ]
  11. Length of Hospital Stay [ Time Frame: during hospitalization (approximately 3-8 days) ]
  12. Wound Infection Rates [ Time Frame: during hospitalization (approximately 3-8 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT01986946


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Erin L Manning, MD/PhD Duke University Hospital Department of Anesthesiology
Principal Investigator: Carlos Bagley, MD Duke University Hospital Department of Neurosurgery
Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01986946    
Other Study ID Numbers: Pro00041252
First Posted: November 19, 2013    Key Record Dates
Results First Posted: November 11, 2016
Last Update Posted: February 23, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents