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Lack of recruitment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous opioids | Experimental | 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. |
|
| Epidural Catheter | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Catheter - Dilaudid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain as Assessed by Visual Analogue Scale (VAS) | The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With Perioperative Analgesia | 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). | Post-operative Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin L Manning, MD/PhD | Duke University Hospital Department of Anesthesiology | Principal Investigator |
| Carlos Bagley, MD | Duke University Hospital Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14612482 | Background | Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455. | |
| 22486142 | Background | Abrishamkar S, Eshraghi N, Feizi A, Talakoub R, Rafiei A, Rahmani P. Analgesic effects of ketamine infusion on postoperative pain after fusion and instrumentation of the lumbar spine: a prospective randomized clinical trial. Med Arh. 2012;66(2):107-10. doi: 10.5455/medarh.2012.66.107-110. |
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17 participants consented in the study, 3 participants were not randomized in the study due to not having the surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid). |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Post-operative Pain as Assessed by Visual Analogue Scale (VAS) | The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. | Participant that provided a VAS score at postoperative day 1 time point. | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 1 |
|
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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 | 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. Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Surgical and medical procedures |
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Enrollment was terminated when co-PI/coordinator left Duke. No surgical collaborators would enroll subjects. Low enrollment of the study significantly affected the analysis, as both study arms were expected to have 100 participants each.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Manning | Duke University Hospital | 919-681-3551 | erin.manning@duke.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Dilaudid | Drug | Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid). |
|
| Patient Satisfaction With Perioperative Analgesia | 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). | 6-Week Follow up Visit |
| Patient Satisfaction With Overall Care | Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). | 6-Week Follow up Visit |
| Number of Participants With Events of Special Interest | Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection. | Post-operative Day 30 |
| Number of Participants With Adverse Events Related to the Study | 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-week Follow up Visit |
| Total Post-operative Opioid Consumption | during hospitalization (approximately 3-8 days) |
| Number of Participants Experiencing Delirium | Post-operative Day 1 |
| Number of Participants Experiencing Delirium | Post-operative Day 2 |
| Number of Participants Experiencing Delirium | Post-operative Day 3 |
| Number of Participants Readmitted to Hospital Within 30 Days of Surgery | Post-operative Day 30 |
| Length of Hospital Stay | during hospitalization (approximately 3-8 days) |
| Wound Infection Rates | during hospitalization (approximately 3-8 days) |
| 15125846 | Background | Sekar C, Rajasekaran S, Kannan R, Reddy S, Shetty TA, Pithwa YK. Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004 May-Jun;4(3):261-4. doi: 10.1016/j.spinee.2003.11.009. |
| 9280026 | Background | Cohen BE, Hartman MB, Wade JT, Miller JS, Gilbert R, Chapman TM. Postoperative pain control after lumbar spine fusion. Patient-controlled analgesia versus continuous epidural analgesia. Spine (Phila Pa 1976). 1997 Aug 15;22(16):1892-6; discussion 1896-7. doi: 10.1097/00007632-199708150-00016. |
| 15644759 | Background | Sucato DJ, Duey-Holtz A, Elerson E, Safavi F. Postoperative analgesia following surgical correction for adolescent idiopathic scoliosis: a comparison of continuous epidural analgesia and patient-controlled analgesia. Spine (Phila Pa 1976). 2005 Jan 15;30(2):211-7. doi: 10.1097/01.brs.0000150832.53604.64. |
| 16261108 | Background | Yukawa Y, Kato F, Ito K, Terashima T, Horie Y. A prospective randomized study of preemptive analgesia for postoperative pain in the patients undergoing posterior lumbar interbody fusion: continuous subcutaneous morphine, continuous epidural morphine, and diclofenac sodium. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2357-61. doi: 10.1097/01.brs.0000184377.31427.fa. |
| 22850657 | Background | Parker SL, Lerner J, McGirt MJ. Effect of minimally invasive technique on return to work and narcotic use following transforaminal lumbar inter-body fusion: a review. Prof Case Manag. 2012 Sep-Oct;17(5):229-35. doi: 10.1097/NCM.0b013e3182529c05. |
| BG001 | Epidural Catheter | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
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.
|
|
| Secondary | Patient Satisfaction With Perioperative Analgesia | 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). | Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment. | Posted | Mean | Standard Deviation | units on a scale | Post-operative Day 1 |
|
|
|
| Secondary | Patient Satisfaction With Perioperative Analgesia | 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). | Participants who completed the patient satisfaction scale at the 6 week follow up visit. | Posted | Mean | Standard Deviation | units on a scale | 6-Week Follow up Visit |
|
|
|
| Secondary | Patient Satisfaction With Overall Care | Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). | Participants who completed the patient satisfaction scale at the 6 week follow up visit. | Posted | Mean | Standard Deviation | units on a scale | 6-Week Follow up Visit |
|
|
|
| Secondary | Number of Participants With Events of Special Interest | Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection. | Data not collected | Posted | Post-operative Day 30 |
|
|
| Secondary | Number of Participants With Adverse Events Related to the Study | 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. | Posted | Number | participants | 6-week Follow up Visit |
|
|
|
| Secondary | Total Post-operative Opioid Consumption | Posted | Mean | Standard Deviation | oral morphine equivilant (mg) | during hospitalization (approximately 3-8 days) |
|
|
|
| Secondary | Number of Participants Experiencing Delirium | Only participants who had assessment for delirium are include in the analysis. | Posted | Number | participants | Post-operative Day 1 |
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|
|
| Secondary | Number of Participants Experiencing Delirium | Participants who were evaluated for Delirium on Day 2 | Posted | Number | participants | Post-operative Day 2 |
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|
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| Secondary | Number of Participants Experiencing Delirium | Participants who were evaluated for Delirium on Day 3 | Posted | Number | participants | Post-operative Day 3 |
|
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| Secondary | Number of Participants Readmitted to Hospital Within 30 Days of Surgery | Posted | Number | participants | Post-operative Day 30 |
|
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|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | during hospitalization (approximately 3-8 days) |
|
|
|
| Secondary | Wound Infection Rates | Data not collected | Posted | during hospitalization (approximately 3-8 days) |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Epidural Catheter | 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. | 1 | 9 | 0 | 9 |
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| 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 |