bupivacaine has been researched along with Failed Back Surgery Syndrome in 2 studies
Bupivacaine: A widely used local anesthetic agent.
1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide : A piperidinecarboxamide obtained by formal condensation of the carboxy group of N-butylpipecolic acid with the amino group of 2,6-dimethylaniline.
bupivacaine : A racemate composed of equimolar amounts of dextrobupivacaine and levobupivacaine. Used (in the form of its hydrochloride hydrate) as a local anaesthetic.
Failed Back Surgery Syndrome: A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.
| Excerpt | Relevance | Reference |
|---|---|---|
| "This is a retrospective analysis of all patients with lumbar failed back surgery syndrome (FBSS) who were trialed with a combination of hydromorphone and bupivacaine with a temporary externalized IT catheter from March 2007 to June 2014." | 3.88 | Intrathecal Trialing of Continuous Infusion Combination Therapy With Hydromorphone and Bupivacaine in Failed Back Surgery Patients. ( Ali, O; Aziz, N; Galica, RJ; Hayek, SM; Katta, S; McEwan, MT; Sondhi, N; Veizi, E, 2018) |
| " The purpose of this study was to evaluate the efficacy of using a rigorous treatment algorithm for trialing and implanting IT pumps with hydromorphone and bupivacaine in managing a more homogeneous population of post-laminectomy syndrome or failed back surgery syndrome (FBSS) patients." | 3.83 | Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device. ( Hanes, M; Hayek, SM; Veizi, E, 2016) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 2 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Galica, RJ | 1 |
| Hayek, SM | 2 |
| Veizi, E | 2 |
| McEwan, MT | 1 |
| Katta, S | 1 |
| Ali, O | 1 |
| Aziz, N | 1 |
| Sondhi, N | 1 |
| Hanes, M | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study[NCT04312685] | 120 participants (Anticipated) | Interventional | 2020-07-27 | Enrolling by invitation | |||
| A Randomized Double Blind Cross-over Trial of Continuous Intrathecal Infusion for Assessing Patients With Chronic Non-cancer Pain Who Would Benefit From Treatment With Intrathecal Drug Delivery System (IDDS) Implant[NCT03523000] | Phase 4 | 36 participants (Actual) | Interventional | 2017-10-18 | Completed | ||
| Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)[NCT03876158] | Phase 4 | 0 participants (Actual) | Interventional | 2019-10-31 | Withdrawn (stopped due to The study will not be conducted by Dr Lubenow) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
AE is any untoward medical occurrence in the patient which does not necessarily have a causal relationship with this infusion treatment (NCT03523000)
Timeframe: Assessing any AEs that occur from baseline (Day 1) through the 12-month post-implant clinic follow up
| Intervention | Adverse events (Number) |
|---|---|
| All Study Participants | 9 |
Number of participants that had increases or decreases in the dose or frequency of pain medication (NCT03523000)
Timeframe: Assessing any changes in pain medications from baseline (Day 1) through the 12-month post-implant clinic follow up
| Intervention | Participants (Count of Participants) |
|---|---|
| Active Solution Followed by Inactive Place Solution | 0 |
| Inactive Placebo Solution Followed by Active Solution | 3 |
Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever (NCT03523000)
Timeframe: Comparing change in NRS from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3)
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | End of intrathecal infusion of solution (Day 2) | End of intrathecal infusion of solution (Day 3) | |
| Active Solution Followed by Inactive Placebo Solution | 6.5 | 3.67 | 4.25 |
| Inactive Placebo Solution Followed by Active Solution | 6.75 | 3.69 | 6.73 |
Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever (NCT03523000)
Timeframe: Comparing change in NRS from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3)
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | End of intrathecal infusion of solution (Day 2) | End of intrathecal infusion of solution (Day 3) | |
| Active Solution Followed by Inactive Placebo Solution | 8.40 | 4.13 | 4.38 |
| Inactive Placebo Solution Followed by Active Solution | 8.00 | 4.19 | 6.73 |
Oswestry Disability Index (ODI) This scale based on a questionnaire of activities measures the impact of pain on multiple factors within a patient's daily life. Higher values represent worse outcomes, or a higher impact from pain on the patient's daily life. The total score range is 0-50. Subcategories include: 0-4: no disability. 5-14: mild disability. 15-24: moderate disability. 25-34: sever disability. 35-50: completely disabled. (NCT03523000)
Timeframe: Comparing change in ODI from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3)
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Baseline | End of intrathecal infusion of solution (Day 3) | |
| Active Solution Followed by Inactive Placebo Solution | 27.13 | 20.38 |
| Inactive Placebo Solution Followed by Active Solution | 26.81 | 27.07 |
The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. PainDETECT is a scale 0 to 38, with 0 being no disability to 38 being max disability. (NCT03523000)
Timeframe: Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3)
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Baseline | End of intrathecal infusion of solution (Day 3) | |
| Active Solution Followed by Inactive Placebo Solution | 16.4 | 10.81 |
| Inactive Placebo Solution Followed by Active Solution | 13.31 | 15.27 |
The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. PainDETECT is a scale of 0 to 35, with 0 being no disability to 35 being max disability. (NCT03523000)
Timeframe: Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3)
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Baseline | End of intrathecal infusion of solution (Day 3) | |
| Active Solution Followed by Inactive Placebo Solution | 15.047 | 10.19 |
| Inactive Placebo Solution Followed by Active Solution | 11.94 | 14.27 |
Patient Global Impression of Change (PGIC) scale is a seven-point single-item scale ranging from 7 'very much worse' to 1 'very much improved'. (NCT03523000)
Timeframe: Comparing change in PGIC from end of intrathecal infusion of solution 1 (Day 2), to end of intrathecal infusion of solution 2 (Day 3)
| Intervention | score on a scale (Mean) | |
|---|---|---|
| End of intrathecal infusion of solution (Day 2) | End of intrathecal infusion of solution (Day 3) | |
| Active Solution Followed by Inactive Placebo Solution | 4.53 | 4.07 |
| Inactive Placebo Solution Followed by Active Solution | 4.66 | 2.48 |
TSQ is a questionnaire to rate level of satisfaction or dissatisfaction with the Intrathecal Drug Delivery- patients were asked preference for either intrathecal solution. Patient preferences for each solution were measured. This data represents the total number of patient's that received a trial and the total number of patients who preferred each solution. Higher values indicate a greater number of study participants preferred a specific arm. Patients with no preference are listed separately. (NCT03523000)
Timeframe: Up to one year
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Intrathecal Infusion 1- Sequence 1 | Intrathecal Infusion 2- Sequence 1 | No preference- Sequence1 | Intrathecal Infusion 1- Sequence 2 | Intrathecal Infusion 2- Sequence 2 | No preference- Sequence 2 | |
| All Study Participants | 11 | 2 | 2 | 5 | 11 | 0 |
2 other studies available for bupivacaine and Failed Back Surgery Syndrome
| Article | Year |
|---|---|
Intrathecal Trialing of Continuous Infusion Combination Therapy With Hydromorphone and Bupivacaine in Failed Back Surgery Patients.
Topics: Aged; Analgesics; Bupivacaine; Dose-Response Relationship, Drug; Drug Therapy, Combination; Failed B | 2018 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |
Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Bupivacaine; Coho | 2016 |