Low Back PainPhase 4NCT05092828
Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery
A Phase 4 study testing Intrathecal Morphine Injection and Pain Relieving in people with Low Back Pain, run by Sonoran Spine Research and Education Foundation at 2 sites in United States.
Trial summary
This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intrathecal Morphine Injection and Pain Relieving
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2021to 2 Dec 2023
- Phase
- Phase 4
- 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
- Adult patients 18 years and older with a diagnosis of adult or degenerative scoliosis,
- Patients meeting criteria for surgical correction involving back and/or leg pain
- Fusion of 4+ levels,
- Competency to undergo informed consent process,
- Medical clearance for spinal fusion surgery,
Who cannot join
- Patients with lumbar spine inaccessible for intrathecal Duragesic (fused L2-S1)
- Patients undergoing 3 or less levels of fusion
- Patients with neuromuscular disease
- Opioid intolerance or dependence
- Severe coexisting diseases
- ASA III
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Sonoran Spine in Collaboration with HonorHealth
Tempe, Arizona, 85281
Biodun A Adeniyi, MBBS, MS, 623-683-8123, biodun@sonoranspine.com
- Not yet recruiting
Sonoran Spine
Tempe, Arizona, 85281
Biodun Adeniyi, MBBS, MS, 480-597-3138
About this study
Official title: Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery: A Prospective, Randomized Clinical Controlled Trial
This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
Read the detailed description
Background Deformity surgery is considered one of the most painful procedures patients can undergo in medicine today. Stringent protocols for pain management have done much to dramatically increase patient satisfaction, but the procedure still lags considerably behind advances in pain control when compared to other procedures such as total joint surgery. Specifically, it has been reported that over half of patients undergoing spine surgery report inadequate pain control the first 24 hours after surgery. Uncontrolled pain has been shown to correlate with prolonged hospital stays, delayed ambulation, poor functional outcomes, and increased risk for the development of chronic pain. Furthermore, the large amount of narcotics given to patients in an attempt to mitigate their pain postoperatively often leads to significant complications in their own right, such as ileus, mental status changes, and nausea. New modalities to treat postoperative pain, especially in the initial days following deformity correction, are needed.
Intrathecal (subarachnoid) injection of morphine has been used to treat severe pain since the 1970's. Its efficacy in treating postoperative pain has been well documented in various specialties including obstetrics, oncology, general surgery, and orthopedic surgery. Specific to spine surgery, intrathecal morphine is an attractive option given the access and visualization of the thecal sac in addition to the high demand of pain control required postoperatively. However, there remains no definitive consensus regarding the use of intrathecal morphine in spine surgery. Current literature is limited by few randomized trials, small sample sizes, heterogeneity of outcomes recorded, and an unclear association with complications. Additionally, there is a paucity of data dedicated to patients undergoing deformity correction. Accordingly, there is a need for high-quality trials to investigate the role of intrathecal morphine in adult spinal deformity surgery.
In this study, we hypothesized that the use of intrathecal morphine will significantly reduce post-operative pain after deformity surgery, reduce opioid utilization, decrease hospital stay, allow for earlier ambulation, increase patient satisfaction, and have comparable complications to traditional pain management strategies. This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
- Conditions
- Low Back Pain
- Being tested
- Intrathecal Morphine Injection, Pain Relieving
- 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.
Intrathecal Morphine InjectionDrug
Also called Subarachnoid injection of morphine
In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.
Pain RelievingDrug
Also called Standard Post-operative pain medications other than intrathecal morphine
Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Patients in this group will receive intrathecal morphine in addition to standard post-operative pain medications Receives: Drug: Intrathecal Morphine Injection |
| Control Group | Active comparator | Patients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine Receives: Drug: Pain Relieving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain Oswesty Disability Index and Scoliosis Research Society Questionnaire
Measured: preoperative
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 6 week, post operative
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 3 months post operative
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 1 year post operative
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Measured: 2-year follow up
Secondary outcomes (5)
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Measured: Preoperative
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Measured: 6 weeks Post Operative
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Measured: 3 months Post Operative
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Measured: 1 year Post Operative
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Measured: 2 year Post Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Dec 2021
- Primary completion2 Dec 2022 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonoran Spine Research and Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chang, MD, Sonoran Spine Research and Education Foundation
- Investigators
- Michael S Chang, MD, Principal investigator, Sonoran Spine Research and Education FoundationAndrew Chung, DO, Principal investigator, Sonoran Spine Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092828
- Sponsor's protocol ID
- SS-MSC-001
- Status last verified
- May 2022
- First submitted
- 16 Sep 2021
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery: A Prospective, Randomized Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT05092828
- Acronym / sponsor ID
- SS-MSC-001
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sonoran Spine Research and Education FoundationUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 2 Dec 2022 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 26 Oct 2021 (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.
This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
Detailed description
Background Deformity surgery is considered one of the most painful procedures patients can undergo in medicine today. Stringent protocols for pain management have done much to dramatically increase patient satisfaction, but the procedure still lags considerably behind advances in pain control when compared to other procedures such as total joint surgery. Specifically, it has been reported that over half of patients undergoing spine surgery report inadequate pain control the first 24 hours after surgery. Uncontrolled pain has been shown to correlate with prolonged hospital stays, delayed ambulation, poor functional outcomes, and increased risk for the development of chronic pain. Furthermore, the large amount of narcotics given to patients in an attempt to mitigate their pain postoperatively often leads to significant complications in their own right, such as ileus, mental status changes, and nausea. New modalities to treat postoperative pain, especially in the initial days following deformity correction, are needed.
Intrathecal (subarachnoid) injection of morphine has been used to treat severe pain since the 1970's. Its efficacy in treating postoperative pain has been well documented in various specialties including obstetrics, oncology, general surgery, and orthopedic surgery. Specific to spine surgery, intrathecal morphine is an attractive option given the access and visualization of the thecal sac in addition to the high demand of pain control required postoperatively. However, there remains no definitive consensus regarding the use of intrathecal morphine in spine surgery. Current literature is limited by few randomized trials, small sample sizes, heterogeneity of outcomes recorded, and an unclear association with complications. Additionally, there is a paucity of data dedicated to patients undergoing deformity correction. Accordingly, there is a need for high-quality trials to investigate the role of intrathecal morphine in adult spinal deformity surgery.
In this study, we hypothesized that the use of intrathecal morphine will significantly reduce post-operative pain after deformity surgery, reduce opioid utilization, decrease hospital stay, allow for earlier ambulation, increase patient satisfaction, and have comparable complications to traditional pain management strategies. This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Drug: Intrathecal Morphine InjectionPatients in this group will receive intrathecal morphine in addition to standard post-operative pain medications |
| Control Group | Active comparator | Drug: Pain RelievingPatients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients 18 years and older with a diagnosis of adult or degenerative scoliosis,
- Patients meeting criteria for surgical correction involving back and/or leg pain
- Fusion of 4+ levels,
- Competency to undergo informed consent process,
- Medical clearance for spinal fusion surgery,
Key exclusion criteria (6 listed)
- Patients with lumbar spine inaccessible for intrathecal Duragesic (fused L2-S1)
- Patients undergoing 3 or less levels of fusion
- Patients with neuromuscular disease
- Opioid intolerance or dependence
- Severe coexisting diseases
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 |
|---|---|---|
| Intrathecal Morphine InjectionAlso: Subarachnoid injection of morphineIn addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group. | Drug | Study Group |
| Pain RelievingAlso: Standard Post-operative pain medications other than intrathecal morphinePatient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine | Drug | Control Group |
Primary outcome
Pain and Outcome Assessment
Time frame: preoperative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain Oswesty Disability Index and Scoliosis Research Society Questionnaire
Pain and Outcome Assessment
Time frame: 6 week, post operative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain and Outcome Assessment
Time frame: 3 months post operative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain and Outcome Assessment
Time frame: 1 year post operative
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain and Outcome Assessment
Time frame: 2-year follow up
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
5 secondary outcomes
Pain medications
Time frame: Preoperative
Pain medications
Time frame: 6 weeks Post Operative
Pain medications
Time frame: 3 months Post Operative
Pain medications
Time frame: 1 year Post Operative
Pain medications
Time frame: 2 year Post Operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
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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.
Michael S Chang, MD principal investigator
Sonoran Spine Research and Education Foundation
Andrew Chung, DO principal investigator
Sonoran Spine Research and Education Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal Morphine Injection and Pain Relieving in people with Low Back Pain, run by Sonoran Spine Research and Education Foundation at 2 sites 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 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 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biodun Adeniyi, MBBS, MS (4805973138, biodun@sonoranspine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Outcome Assessment (time frame: preoperative). The study lists 5 primary outcomes in all. 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 13 May 2022.