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The surgical team has difficulty to find level 1 and 2 fusions for the study.
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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.
Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Controlled Epidural Analgesia | Experimental | Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours |
|
| Intravenous patient-controlled analgesia | Sham Comparator | Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Score (VAS) | Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain). | VAS score at postoperative 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enas Kandil, MD | University of Texas Southwestern Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9068 | United States | ||
| University Of Texas Southwestern Medical Center, Zale University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient-Controlled Epidural Analgesia | Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine. |
| FG001 | Intravenous Patient-controlled Analgesia | Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient-Controlled Epidural Analgesia | Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Year | Analysis sample is lower than total enrollment number because all participants could not completed study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Pain Score (VAS) | Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain). | Spinal fusion surgeries level 1 to 3. | Posted | Mean | Standard Deviation | units on a scale | VAS score at postoperative 24 hours |
|
All unexpected or serious adverse events have been monitored during hospital stay and 6-week follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient-Controlled Epidural Analgesia | Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Enas Kandil | UT Southwestern Medical Center | 214/648-9374 | Enas.Kandil@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2022 | Aug 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2019 | Aug 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004091 | Hydromorphone |
| D005283 | Fentanyl |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Hydromorphone | Drug | Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). |
|
|
| Fentanyl | Drug | Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine. |
|
|
| Dallas |
| Texas |
| 75390 |
| United States |
| Withdrawal by Subject |
|
| Intervention not received according to the protocol. |
|
| Physician Decision |
|
| Randomization not applied |
|
| BG001 |
| Intravenous Patient-controlled Analgesia |
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Years | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Preoperative Pain Score | VAS pain score on the scale of 0 to 100 (0=no pain, 100= worst pain) | Mean | Standard Deviation | units on a scale (0 to 100) |
|
Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Intravenous Patient-controlled Analgesia | Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). | 0 | 21 | 0 | 21 | 0 | 21 |
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| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |