Low Back PainNCT02293525
Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
A study testing ReLeaf catheter, Ropivacaine and Saline in people with Low Back Pain, run by Vital 5, LLC.
Trial summary
The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- ReLeaf catheter, Ropivacaine and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature
- Diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy
- Physically and mentally willing to comply with the study requirements
- Signed the study informed consent
Who cannot join
- Lumbar spine disease requiring more than two levels of instrumentation
- Any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery
- Patients requiring iliac crest bone graft for the procedure
- Intra-operative durotomy
- Any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months
- Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse)
Show all 13Show fewer
- Diagnosed with Severe Depression and on treatment
- Active infection at the operative level or a symptomatic infection
- Diagnosed systemic disease that would affect the subject's welfare or overall outcome of the research study (i.e. Paget's disease, renal osteodystrophy, Lupus etc)
- Is pregnant or breast feeding
- Has any active malignancy or spinal arthrodesis being performed for a tumor decompression
- Has a known allergy to local analgesics
- Pending litigation related to back pain or injury or Worker's Compensation
About this study
Official title: Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.
Read the detailed description
Posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. However, severe postoperative pain is a significant adverse outcome in patients who have undergone a lumbar spinal fusion procedure. This pain may delay mobilization and decrease compliance with physical, occupational, or pulmonary physiotherapy.
Pain symptoms may worsen with activity and ambulation due to reflex spasms of the paraspinal muscles elicited by pain from the wound. A local anesthetic agent administered immediately after surgery into the tissue surrounding the wound addresses the pain source for less than four hours. Therefore, it is reasonable to consider continuous local anesthetic infusion, which may limit local pain mediators for a longer duration.
Continuous local anesthetic infusion into the paraspinal musculature with the ReLeaf catheter has the potential to reduce pain, narcotic demand \& usage, and accelerate the rate of recovery in lumbar spinal fusion patients.
- Conditions
- Low Back Pain
- Being tested
- ReLeaf catheter, Ropivacaine, Saline, Morphine, Oxycodone
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReLeaf catheterDevice
Continuous infusion rate 10ml/hr (5ml/side)
RopivacaineDrug
Also called Naropin
SalineDrug
MorphineDrug
Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg
OxycodoneDrug
Also called Oxycontin, Roxicodone, Oxecta
10mg every 4-6 hours
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Continuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours) Receives: Device: ReLeaf catheter; Drug: Ropivacaine; Drug: Morphine; Drug: Oxycodone |
| Saline | Placebo comparator | Continuous saline infusion until catheter removal (typically 36 hours) Receives: Device: ReLeaf catheter; Drug: Saline; Drug: Morphine; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Mean VAS pain score at 24 hours post-procedure)
Mean VAS pain score at 24 hours post-procedure
Measured: 24 hours
Secondary outcomes (2)
Medication Use
Narcotic use from surgery through 3 months post-operative
Measured: 3 months
Adverse Events
Occurrence of adverse events through 3 months post-operative
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: No subjects were enrolled and the sponsor suspended support at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital 5, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293525
- Sponsor's protocol ID
- CLI-001-0201
- Status last verified
- Jan 2016
- First submitted
- 27 Oct 2014
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16261108Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80. doi: 10.1097/00000542-200407000-00027.
PubMed 15220788Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44.
PubMed 14693613Elder JB, Hoh DJ, Wang MY. Postoperative continuous paravertebral anesthetic infusion for pain control in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2008 Jan 15;33(2):210-8. doi: 10.1097/BRS.0b013e318160447a.
PubMed 18197109
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
- ClinicalTrials.gov ID
- NCT02293525
- Acronym / sponsor ID
- CLI-001-0201
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled and the sponsor suspended support at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vital 5, LLCIndustry (pharma, biotech, devices)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery. One half of the patients will receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.
Detailed description
Posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. However, severe postoperative pain is a significant adverse outcome in patients who have undergone a lumbar spinal fusion procedure. This pain may delay mobilization and decrease compliance with physical, occupational, or pulmonary physiotherapy.
Pain symptoms may worsen with activity and ambulation due to reflex spasms of the paraspinal muscles elicited by pain from the wound. A local anesthetic agent administered immediately after surgery into the tissue surrounding the wound addresses the pain source for less than four hours. Therefore, it is reasonable to consider continuous local anesthetic infusion, which may limit local pain mediators for a longer duration.
Continuous local anesthetic infusion into the paraspinal musculature with the ReLeaf catheter has the potential to reduce pain, narcotic demand \& usage, and accelerate the rate of recovery in lumbar spinal fusion patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Device: ReLeaf catheter, Drug: Ropivacaine, Drug: Morphine, Drug: OxycodoneContinuous 0.2% Ropivacaine infusion until catheter removal (typically 36 hours) |
| Saline | Placebo comparator | Device: ReLeaf catheter, Drug: Saline, Drug: Morphine, Drug: OxycodoneContinuous saline infusion until catheter removal (typically 36 hours) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletally mature
- Diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy
- Physically and mentally willing to comply with the study requirements
- Signed the study informed consent
Key exclusion criteria (13 listed)
- Lumbar spine disease requiring more than two levels of instrumentation
- Any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery
- Patients requiring iliac crest bone graft for the procedure
- Intra-operative durotomy
- Any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReLeaf catheterContinuous infusion rate 10ml/hr (5ml/side) | Device | Ropivacaine, Saline |
| RopivacaineAlso: Naropin | Drug | Ropivacaine |
| Saline | Drug | Saline |
| MorphinePatient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg | Drug | Ropivacaine, Saline |
| OxycodoneAlso: Oxycontin, Roxicodone, Oxecta10mg every 4-6 hours | Drug | Ropivacaine, Saline |
Primary outcome
Pain (Mean VAS pain score at 24 hours post-procedure)
Time frame: 24 hours
Mean VAS pain score at 24 hours post-procedure
2 secondary outcomes
Medication Use
Time frame: 3 months
Adverse Events
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Background: PubMed 16261108Yukawa 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.
- Background: PubMed 15220788Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80. doi: 10.1097/00000542-200407000-00027.
- Background: PubMed 14693613Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B, Guberti A, Massari L. The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2004 Jan;98(1):166-172. doi: 10.1213/01.ANE.0000093310.47375.44.
- Background: PubMed 18197109Elder JB, Hoh DJ, Wang MY. Postoperative continuous paravertebral anesthetic infusion for pain control in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2008 Jan 15;33(2):210-8. doi: 10.1097/BRS.0b013e318160447a.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ReLeaf catheter, Ropivacaine and Saline in people with Low Back Pain, run by Vital 5, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (Mean VAS pain score at 24 hours post-procedure) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293525, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.