Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
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|ClinicalTrials.gov Identifier: NCT03115151|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Bupivacaine Drug: Hydromorphone Drug: Fentanyl||Phase 4|
Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:
- Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Patient-Controlled Epidural Analgesia
Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours
Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
Other Name: Bupivacaine Hydrochloride
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
Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
Other Name: DILAUDID
- Visual Analog Pain Score (VAS) [ Time Frame: Postoperative VAS score at 24 hours ]Postoperative Visual Analog Pain Score following lumbar fusion surgery
- Total opioid consumption [ Time Frame: Postoperative the first 24 hours ]Postoperative opioid consumption
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
|Contact: Enas Kandil, MD||214/648-9374||Enas.Kandil@UTSouthwestern.edu|
|Contact: Emily Melikman, MD||214-645-7011||Emily.Melikman@utsouthwestern.edu|
|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|
|Study Chair:||Seema Dave||UT Southwestern Medical Center|