Lumbar Spine Fusion, Pain, Back Pain
Conditions
Brief summary
1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia. 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.
Interventions
DRUGDilaudid
Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
OTHEREpidural 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery
Exclusion criteria
* Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain as Assessed by Visual Analogue Scale (VAS) | Postoperative day 1 | The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Overall Care | 6-Week Follow up Visit | Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). |
| Number of Participants With Events of Special Interest | Post-operative Day 30 | Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection. |
| Number of Participants With Adverse Events Related to the Study | 6-week Follow up Visit | 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. |
| Total Post-operative Opioid Consumption | during hospitalization (approximately 3-8 days) | — |
| Patient Satisfaction With Perioperative Analgesia | Post-operative Day 1 | 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). |
| 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) | — |
| Number of Participants Experiencing Delirium | Post-operative Day 1 | — |
Countries
United States
Participant flow
Recruitment details
17 participants consented in the study, 3 participants were not randomized in the study due to not having the surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 5 |
| 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. | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Intravenous Opioids | Epidural Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Gender Female | 4 Participants | 8 Participants | 12 Participants |
| Gender Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 0 / 5 | 1 / 9 |
Outcome results
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.
Time frame: Postoperative day 1
Population: Participant that provided a VAS score at postoperative day 1 time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Opioids | Post-operative Pain as Assessed by Visual Analogue Scale (VAS) | 36.33 units on a scale | Standard Deviation 26.66 |
| Epidural Catheter | Post-operative Pain as Assessed by Visual Analogue Scale (VAS) | 40.63 units on a scale | Standard Deviation 29.09 |
Secondary
Length of Hospital Stay
Time frame: during hospitalization (approximately 3-8 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Opioids | Length of Hospital Stay | 4.4 days | Standard Deviation 1.02 |
| Epidural Catheter | Length of Hospital Stay | 4.33 days | Standard Deviation 1.41 |
Secondary
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 3
Population: Participants who were evaluated for Delirium on Day 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Opioids | Number of Participants Experiencing Delirium | 0 participants |
| Epidural Catheter | Number of Participants Experiencing Delirium | 0 participants |
Secondary
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 2
Population: Participants who were evaluated for Delirium on Day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Opioids | Number of Participants Experiencing Delirium | 0 participants |
| Epidural Catheter | Number of Participants Experiencing Delirium | 0 participants |
Secondary
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 1
Population: Only participants who had assessment for delirium are include in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Opioids | Number of Participants Experiencing Delirium | 0 participants |
| Epidural Catheter | Number of Participants Experiencing Delirium | 0 participants |
Secondary
Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Time frame: Post-operative Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Opioids | Number of Participants Readmitted to Hospital Within 30 Days of Surgery | 0 participants |
| Epidural Catheter | Number of Participants Readmitted to Hospital Within 30 Days of Surgery | 0 participants |
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.
Time frame: 6-week Follow up Visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous Opioids | Number of Participants With Adverse Events Related to the Study | 0 participants |
| Epidural Catheter | Number of Participants With Adverse Events Related to the Study | 0 participants |
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.
Time frame: Post-operative Day 30
Population: Data not collected
Secondary
Patient Satisfaction With Overall Care
Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Time frame: 6-Week Follow up Visit
Population: Participants who completed the patient satisfaction scale at the 6 week follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Opioids | Patient Satisfaction With Overall Care | 1 units on a scale | Standard Deviation 0 |
| Epidural Catheter | Patient Satisfaction With Overall Care | 1.5 units on a scale | Standard Deviation 0.71 |
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).
Time frame: 6-Week Follow up Visit
Population: Participants who completed the patient satisfaction scale at the 6 week follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Opioids | Patient Satisfaction With Perioperative Analgesia | 2 units on a scale | Standard Deviation 0.82 |
| Epidural Catheter | Patient Satisfaction With Perioperative Analgesia | 1.5 units on a scale | Standard Deviation 0.71 |
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).
Time frame: Post-operative Day 1
Population: Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Opioids | Patient Satisfaction With Perioperative Analgesia | 2.4 units on a scale | Standard Deviation 1.02 |
| Epidural Catheter | Patient Satisfaction With Perioperative Analgesia | 1.29 units on a scale | Standard Deviation 0.7 |
Secondary
Total Post-operative Opioid Consumption
Time frame: during hospitalization (approximately 3-8 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Opioids | Total Post-operative Opioid Consumption | 438.52 oral morphine equivilant (mg) | Standard Deviation 292.87 |
| Epidural Catheter | Total Post-operative Opioid Consumption | 410.42 oral morphine equivilant (mg) | Standard Deviation 501.09 |
Secondary
Wound Infection Rates
Time frame: during hospitalization (approximately 3-8 days)
Population: Data not collected