Degenerative Disc Disease LumbarMMANCT01861743
Multimodal Analgesia Versus Routine Care Pain Management
A study testing Multimodal Analgesia in people with Degenerative Disc Disease Lumbar and Spinal Stenosis, run by Rush University Medical Center at 1 site in United States.
Trial summary
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease Lumbar, Spinal Stenosis, Lumbar Spondylolisthesis
- What is being tested?
- Multimodal Analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing single level MIS-TLIF
- Patients able to provide informed consent
Who cannot join
- Allergies or other contraindications to medicines in the protocol
- Current liver disease with documented liver function test abnormality
- Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
- Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
- Active alcohol dependence
- Active illicit drug dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center-Orthopedic Spine
Chicago, Illinois, 60612
About this study
Official title: Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.
Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).
Read more
A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.
Read the detailed description
We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:
- decreased post-operative pain compared to patients receiving usual care for pain management.
- shorter hospital LOS compared to patients receiving usual care pain management.
- fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
- improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
- better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.
- Being tested
- Multimodal Analgesia, Patient controlled analgesia
- Keywords
- Multi-modal Pain Management, Lumbar fusion, misTLIF
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal AnalgesiaOther
Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
Patient controlled analgesiaOther
Subjects will be treated with patient controlled narcotic analgesia for pain management.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal analgesia | Experimental | multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols. Receives: Other: Multimodal Analgesia |
| Patient Controlled analgesia | Active comparator | Pain management using patient controlled narcotic analgesia. Receives: Other: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain scale
(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
Measured: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
Secondary outcomes (1)
Patient satisfaction
At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no)
Measured: Post operatively (avg: 1-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startApr 2013
- Primary completion31 Dec 2016
- Study completionDec 2017
Why it stopped: data was not collected accurately
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc Disease LumbarStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank M. Phillips, MD, Rush University Medical Center
- Investigators
- Frank M Phillips, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861743
- Sponsor's protocol ID
- 13020402
- Acronym
- MMA
- Status last verified
- Aug 2018
- First submitted
- 8 May 2013
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708.
PubMed 21372654Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.
PubMed 20375829
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01861743
- Acronym / sponsor ID
- MMA / 13020402
- Keywords
- Multi-modal Pain Management, Lumbar fusion, misTLIF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: data was not collected accurately
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 May 2013 (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.
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.
Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).
A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.
Detailed description
We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:
- decreased post-operative pain compared to patients receiving usual care for pain management.
- shorter hospital LOS compared to patients receiving usual care pain management.
- fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
- improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
- better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal analgesia | Experimental | Other: Multimodal Analgesiamultiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols. |
| Patient Controlled analgesia | Active comparator | Other: Patient controlled analgesiaPain management using patient controlled narcotic analgesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing single level MIS-TLIF
- Patients able to provide informed consent
Key exclusion criteria (6 listed)
- Allergies or other contraindications to medicines in the protocol
- Current liver disease with documented liver function test abnormality
- Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
- Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
- Active alcohol dependence
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 |
|---|---|---|
| Multimodal AnalgesiaSubjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain. | Other | Multimodal analgesia |
| Patient controlled analgesiaSubjects will be treated with patient controlled narcotic analgesia for pain management. | Other | Patient Controlled analgesia |
Primary outcome
Numeric pain scale
Time frame: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
1 secondary outcome
Patient satisfaction
Time frame: Post operatively (avg: 1-3 days)
Results and safety
The study was stopped early (reason given: data was not collected accurately). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Results publication: PubMed 21372654Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708.
- Results publication: PubMed 20375829Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.
- Individual participant dataSharing planned: Undecided
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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.
Frank M Phillips, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Analgesia in people with Degenerative Disc Disease Lumbar and Spinal Stenosis, run by Rush University Medical Center 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 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: stopped early, as of the sponsor's last update on 29 Aug 2018. 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. 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 stopped early (reason given: data was not collected accurately). Results are not available in the source record.
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?
Numeric pain scale (time frame: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.). 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 NCT01861743, which also lists 2 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 29 Aug 2018.