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Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115151
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE May 8, 2017
Estimated Primary Completion Date June 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
Visual Analog Pain Score (VAS) [ Time Frame: Postoperative VAS score at 24 hours ]
Postoperative Visual Analog Pain Score following lumbar fusion surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
Total opioid consumption [ Time Frame: Postoperative the first 24 hours ]
Postoperative opioid consumption
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 Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Official Title  ICMJE A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study
Brief Summary Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.
Detailed Description

Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:

  1. Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)
  2. Intravenous Patient-Controlled Analgesia (IV PCA)

Study Interventions - The intervention to be evaluated in this study is epidural analgesia using an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml. The epidural infusion will be continued until it is appropriate to transition the patient to a regimen of oral pain medications. Duration of epidural catheter will be 72 hours a postoperatively.

For subjects in the IV PCA group, the intervention will include post-operative IV PCA with Hydromorphone.

Epidural catheters will be placed by the spine surgeon under direct visualization intra-operatively prior to closing the surgical incision. Intra-operative epidural catheter placement by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy.

Epidurals will be assessed for efficacy/function in the recovery room post-operatively by the APS, and then daily on the floor post-operatively (unless contacted by the floor nurse regarding specific concerns).

Visual analog pain scale (VAS) will be used to evaluate degree of pain at 3, 24, 48, and 72 hours after surgery.

Additionally, both the IV PCA and the epidural PCEA groups may be given additional "rescue" pain medications as needed in the recovery room, and these may be continued through the post-operative period on the floor.

Total study duration is approximately 50 days, which starts from operating room admission for spinal fusion surgery to the first follow-up visit after discharge.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Bupivacaine
    Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
    Other Name: Bupivacaine Hydrochloride
  • Drug: Hydromorphone
    Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
    Other Name: DILAUDID
  • Drug: Fentanyl
    Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
    Other Name: Opioid
Study Arms  ICMJE
  • Experimental: Patient-Controlled Epidural Analgesia
    Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
    Interventions:
    • Drug: Bupivacaine
    • Drug: Fentanyl
  • Sham Comparator: Intravenous patient-controlled analgesia
    Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
    Intervention: Drug: Hydromorphone
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2017)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 4, 2022
Estimated Primary Completion Date June 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult subjects aged 18 years or older
  • Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels

Exclusion Criteria:

  • Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
  • Immunocompromised subject
  • Coagulopathy
  • Severe liver and renal dysfunction
  • Preoperative neurological deficits
  • The dura damage during surgery
  • 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) or opioid (fentanyl) allergy if patient assigned epidural analgesia.
  • Hydromorphone allergy if patient assigned IV PCA
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Enas Kandil, MD 214/648-9374 Enas.Kandil@UTSouthwestern.edu
Contact: Emily Melikman, MD 214-645-7011 Emily.Melikman@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03115151
Other Study ID Numbers  ICMJE STU 092016-061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Seema Dave UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2020

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