Spine FusionPhase 2NCT03476811
Postoperative subQ Pain Control for Spinal Fusion Surgery
A Phase 2 study testing 0.25% Marcaine at 2ml/hr and pain medications and Placement of OnQ Drug pump in people with Spine Fusion and Surgery, run by University of Arizona at 1 site in United States.
Trial summary
Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spine Fusion, Surgery, Pain, Postoperative
- What is being tested?
- 0.25% Marcaine at 2ml/hr and pain medications and Placement of OnQ Drug pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 30 Jun 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient 18 years of age or greater
- Surgery to be done at Banner University Medical Center-Tucson
- Elective Surgeries only
- Lower Thoracic or Lumbar fusions only - Posterior Approach
- Postero or Posterolateral Instrumented Fusions with or without Interbody graft
- Transforaminal Interbody Fusions
- Must be able to cooperate in the daily VAS assessment
Who cannot join
- Patients under 18 years of age
- Prisoners
- Pregnant women
- Hypersensitivity to infusion medication
- Deformity Correction cases requiring osteotomies
- Surgical fusion in acute phase for traumatic injury
- Anterior Lumbar Interbody Fusion, Direct Lateral Interbody Fusion procedures
Trial locations and contacts
1 site in 1 country.
About this study
Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.
Read the detailed description
For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.
- Conditions
- Spine Fusion, Surgery, Pain, Postoperative
- Being tested
- 0.25% Marcaine at 2ml/hr and pain medications, Placement of OnQ Drug pump
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% Marcaine at 2ml/hr and pain medicationsDrug
Also called OnQ Subcutaneous Drug pump
Subcutaneous pain control with OnQ Subcutaneous Drug pump
Placement of OnQ Drug pumpDevice
Subcutaneous placement of OnQ drug pump with normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Normal treatment paradigm (no anesthetic pump) with pain medications, only. |
| Marciano Group | Active comparator | Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications. Receives: Drug: 0.25% Marcaine at 2ml/hr and pain medications |
| Placebo Group | Placebo comparator | OnQ pump with placebo (normal saline at 2ml/hr) and pain medications. Receives: Device: Placement of OnQ Drug pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
A daily Visual Analog Score Pain scale (1-10) for pain severity, (1 least pain, 10 most pain) will be assessed and recorded daily by a blinded assessor.
Measured: From post operative day 1 until patient discharge or 30 days, whichever comes first
Secondary outcomes (5)
Time to discharge
Number of hospital days from time when patient surgery is completed to discharge will be assessed
Measured: from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.
Total Milligrams of IV pain medication
Total milligrams of IV pain medications will be assessed
Measured: from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Total Doses of IV pain medication
Number of doses of IV pain medications will be assessed
Measured: from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Total Milligrams of oral pain medication
Total milligrams of oral pain medications will be assessed
Measured: from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Total Doses of oral pain medication
Total doses of oral pain medications will be assessed
Measured: from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start9 Feb 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 Spine FusionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a comparative trial investigating outcomes in 3 parallel groups. The control group will receive standard of care pain control following surgery, the Marcaine group will receive infusion of FDA approved Marcaine around the operative site following surgery through an FDA approved surgical device. The Placebo group will have the drug delivery device implanted with delivery of saline.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bina, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476811
- Sponsor's protocol ID
- 1712090332
- Status last verified
- May 2022
- First submitted
- 22 Feb 2018
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gottschalk 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 15220788Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
PubMed 11020770Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.
PubMed 21102963Reynolds RA, Legakis JE, Tweedie J, Chung Y, Ren EJ, Bevier PA, Thomas RL, Thomas ST. Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics. Global Spine J. 2013 Mar;3(1):7-14. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2.
PubMed 24436846
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative subQ Pain Control for Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT03476811
- Acronym / sponsor ID
- 1712090332
- Conditions
- Spine Fusion, Surgery, Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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.
Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.
Detailed description
For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This trial is a comparative trial investigating outcomes in 3 parallel groups. The control group will receive standard of care pain control following surgery, the Marcaine group will receive infusion of FDA approved Marcaine around the operative site following surgery through an FDA approved surgical device. The Placebo group will have the drug delivery device implanted with delivery of saline.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Normal treatment paradigm (no anesthetic pump) with pain medications, only. |
| Marciano Group | Active comparator | Drug: 0.25% Marcaine at 2ml/hr and pain medicationsSubcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications. |
| Placebo Group | Placebo comparator | Device: Placement of OnQ Drug pumpOnQ pump with placebo (normal saline at 2ml/hr) and pain medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient 18 years of age or greater
- Surgery to be done at Banner University Medical Center-Tucson
- Elective Surgeries only
- Lower Thoracic or Lumbar fusions only - Posterior Approach
- Postero or Posterolateral Instrumented Fusions with or without Interbody graft
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Prisoners
- Pregnant women
- Hypersensitivity to infusion medication
- Deformity Correction cases requiring osteotomies
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 |
|---|---|---|
| 0.25% Marcaine at 2ml/hr and pain medicationsAlso: OnQ Subcutaneous Drug pumpSubcutaneous pain control with OnQ Subcutaneous Drug pump | Drug | Marciano Group |
| Placement of OnQ Drug pumpSubcutaneous placement of OnQ drug pump with normal saline infusion | Device | Placebo Group |
Primary outcome
Pain control
Time frame: From post operative day 1 until patient discharge or 30 days, whichever comes first
A daily Visual Analog Score Pain scale (1-10) for pain severity, (1 least pain, 10 most pain) will be assessed and recorded daily by a blinded assessor.
5 secondary outcomes
Time to discharge
Time frame: from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first.
Total Milligrams of IV pain medication
Time frame: from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Total Doses of IV pain medication
Time frame: from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Total Milligrams of oral pain medication
Time frame: from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Total Doses of oral pain medication
Time frame: from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- 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 11020770Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
- Background: PubMed 21102963Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21.
- Background: PubMed 24436846Reynolds RA, Legakis JE, Tweedie J, Chung Y, Ren EJ, Bevier PA, Thomas RL, Thomas ST. Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics. Global Spine J. 2013 Mar;3(1):7-14. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.25% Marcaine at 2ml/hr and pain medications and Placement of OnQ Drug pump in people with Spine Fusion and Surgery, run by University of Arizona at 1 site in United States.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 control (time frame: From post operative day 1 until patient discharge or 30 days, whichever comes first). 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 NCT03476811, 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 26 May 2022.