Degenerative Lumbar Spinal StenosisPhase 1/2NCT06447194
Effect of RECK in Posterior Spinal Fusion
A Phase 1/2 study testing Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail in people with Degenerative Lumbar Spinal Stenosis and Degenerative Disc Disease, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degenerative Spondylolisthesis
- What is being tested?
- Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Apr 2027
- Phase
- Phase 1/2
- 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 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-88 years old
- Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.
Who cannot join
- Revision surgeries
- Surgeries indicated for trauma, tumor, or infection
- Preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness
- Known hypersensitivity to any of the RECK components
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.
Read more
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.
Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.
Read the detailed description
Patients will be randomized into two groups. Intraoperatively, they will be given either 1) a 50 mL RECK (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 mL injection of saline (control group). RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. All patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Disease
- Being tested
- Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail, Placebo
- Keywords
- Spine Surgery, Lumbar Fusion, Pain Control, Opioid Utilization, Local Anesthesia, RECK, R.E.C.K., Ropivacaine, Epinephrine, Clonidine, Ketorolac, Randomized Controlled Trial
- Medical subject headings
- Intervertebral Disc Degeneration, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection CocktailDrug
Also called RECK
Please refer to description for interventional group.
PlaceboOther
100mL paraspinal normal saline injection intraoperatively, once.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (RECK) | Experimental | The arm of patients who will be administered "RECK" local anesthesia cocktail:
Ropivacaine 0.125g Clonidine 80 mcg Epinephrine 0.5 mg Ketorolac 30 mg In sterile water 73 mL (total volume of compound is 100 mL)
Given through paraspinal muscle injection once intraoperatively. Receives: Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail |
| Control Group (Placebo) | Placebo comparator | The arm of patients who will be administered a placebo injection:
100 mL Normal Saline
Given through paraspinal muscle injection once intraoperatively. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative VAS Pain Scores
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.
VAS (Visual Analogue Scale) measures pain intensity. The VAS is a 10cm line with two end points representing 0 ("No pain") and 10 ("Pain as bad as it could be"). The patient is asked to rate their pain by placing a marker on the line. A lower score (thus closer to "no pain") is a better outcome.
Measured: 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)
Secondary outcomes (2)
Opioid Utilization
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption.
Measured: Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)
Hospital Length of Stay
Secondary aims: to investigate of effect of RECK injection on hospital length of stay.
Measured: Up to 2 weeks (an average of 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Why it stopped: Study was not feasible due to logistical and implementation challenges. No participants were enrolled and the study will not proceed further.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Ludwig, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447194
- Sponsor's protocol ID
- HP-00109268
- Status last verified
- Jul 2025
- First submitted
- 14 May 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT06447194
- Acronym / sponsor ID
- HP-00109268
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Disease
- Keywords
- Spine Surgery, Lumbar Fusion, Pain Control, Opioid Utilization, Local Anesthesia, RECK, R.E.C.K., Ropivacaine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not feasible due to logistical and implementation challenges. No participants were enrolled and the study will not proceed further.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 7 Jun 2024 (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.
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.
Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.
Detailed description
Patients will be randomized into two groups. Intraoperatively, they will be given either 1) a 50 mL RECK (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 mL injection of saline (control group). RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. All patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention (RECK) | Experimental | Drug: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection CocktailThe arm of patients who will be administered "RECK" local anesthesia cocktail: Ropivacaine 0.125g Clonidine 80 mcg Epinephrine 0.5 mg Ketorolac 30 mg In sterile water 73 mL (total volume of compound is 100 mL) Given through paraspinal muscle injection once intraoperatively. |
| Control Group (Placebo) | Placebo comparator | Other: PlaceboThe arm of patients who will be administered a placebo injection: 100 mL Normal Saline Given through paraspinal muscle injection once intraoperatively. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-88 years old
- Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.
Key exclusion criteria (4 listed)
- Revision surgeries
- Surgeries indicated for trauma, tumor, or infection
- Preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness
- Known hypersensitivity to any of the RECK components
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 |
|---|---|---|
| Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection CocktailAlso: RECKPlease refer to description for interventional group. | Drug | Intervention (RECK) |
| Placebo100mL paraspinal normal saline injection intraoperatively, once. | Other | Control Group (Placebo) |
Primary outcome
Postoperative VAS Pain Scores
Time frame: 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores. VAS (Visual Analogue Scale) measures pain intensity. The VAS is a 10cm line with two end points representing 0 ("No pain") and 10 ("Pain as bad as it could be"). The patient is asked to rate their pain by placing a marker on the line. A lower score (thus closer to "no pain") is a better outcome.
2 secondary outcomes
Opioid Utilization
Time frame: Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days)
Hospital Length of Stay
Time frame: Up to 2 weeks (an average of 4 days)
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 31 Jul 2025.
- 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 1/2 study testing Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail in people with Degenerative Lumbar Spinal Stenosis and Degenerative Disc Disease, run by University of Maryland, Baltimore 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 2 inclusion and 4 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 31 Jul 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Postoperative VAS Pain Scores (time frame: 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.