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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

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Drug: Hydromorphone Drug: Fentanyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : June 12, 2021
Estimated Study Completion Date : September 4, 2022


Arm Intervention/treatment
Experimental: Patient-Controlled Epidural Analgesia
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
Drug: Bupivacaine
Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
Other Name: Bupivacaine Hydrochloride

Drug: Fentanyl
Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
Other Name: Opioid

Sham Comparator: Intravenous patient-controlled analgesia
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
Drug: Hydromorphone
Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
Other Name: DILAUDID




Primary Outcome Measures :
  1. Visual Analog Pain Score (VAS) [ Time Frame: Postoperative VAS score at 24 hours ]
    Postoperative Visual Analog Pain Score following lumbar fusion surgery


Secondary Outcome Measures :
  1. Total opioid consumption [ Time Frame: Postoperative the first 24 hours ]
    Postoperative opioid consumption



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03115151


Contacts
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Contact: Enas Kandil, MD 214/648-9374 Enas.Kandil@UTSouthwestern.edu
Contact: Emily Melikman, MD 214-645-7011 Emily.Melikman@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9068
Contact: Enas Kandil, MD    214-648-9374    Enas.Kandil@UTSouthwestern.edu   
University Of Texas Southwestern Medical Center, Zale University Hospital Recruiting
Dallas, Texas, United States, 75390
Contact: Jessica Moreno, BSN    214-645-0629    Jessica.Moreno@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Chair: Seema Dave UT Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03115151    
Other Study ID Numbers: STU 092016-061
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fentanyl
Hydromorphone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General