Degenerative SpondylolisthesisNCT01513564
Multimodal Perioperative Pain Management
A study testing Postoperative epidural morphine and Local anaesthesia in people with Degenerative Spondylolisthesis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery. The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Spondylolisthesis
- What is being tested?
- Postoperative epidural morphine and Local anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2001to Jun 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels.
Who cannot join
- Previous fusion, metabolic bone disease, severe comorbidity or psychological instability.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Research Unit, Aarhus University, Aalborg Hospital
Aalborg, 9000
About this study
Official title: Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery
Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery.
The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.
Read the detailed description
Major spine surgery is usually associated with high postoperative pain scores and opioid requirements. Epidural analgesia has been reported to be an effective and safe method to control postoperative pain after spinal instrumentation surgery, but the overall effects of pain management on postoperative length of stay and recovery remains debatable.
However, in a multimodal approach, including multimodal non-opioid analgesia to control postoperative pathophysiology and rehabilitation, complications and hospital stay have been reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and abdominal surgery and other procedures, when combined with an enhanced recovery program.
The aim of the study is to assess the effect and safety of a combined analgesic regimen consisting of local anesthetic, intra-operative and post-operative continuous epidural analgesia and a single dose ketorolac together with a fast track rehabilitation program after 360 degree lumbar fusion for degenerative disc disease and spondylolisthesis < 2
- Conditions
- Degenerative Spondylolisthesis
- Being tested
- Postoperative epidural morphine, Local anaesthesia
- Keywords
- Disc disease, Spondylolisthesis
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative epidural morphineDrug
Also called Convalescence after lumbar fusion
The control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program.
Local anaesthesiaDrug
Also called Convalescence after lumbar fusion.
Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment program | Experimental | The control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed.
The intervention group received the same training program but with a faster program plus a higher intensity exercise-training program. Receives: Drug: Postoperative epidural morphine; Drug: Local anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multimodal management of lumbar fusion
Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index
Measured: Two years
Secondary outcomes (1)
Multimodal management of lumbar fusion
Assessment of the effects of at fast track program with ongoing epidural analgesia, multimodal pain treatment including ketorolac and early intensive mobilization and physiotherapy.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2001
- Primary completionDec 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative SpondylolisthesisStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, Aarhus University Hospital, Copenhagen University Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Principal investigator, Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkDavid S. Krum-Moeller, M.D., Study chair, Department of Orthopaedic Surgery, Vejle and Give HospitalLene R. Lauridsen, Study chair, Department of Orthopaedic Surgery, Vejle and Give HospitalHenrik Kehlet, M.D., Study chair, Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513564
- Sponsor's protocol ID
- ON-07-008-RAS
- Status last verified
- May 2015
- First submitted
- 13 Dec 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery
- ClinicalTrials.gov ID
- NCT01513564
- Acronym / sponsor ID
- ON-07-008-RAS
- Conditions
- Degenerative Spondylolisthesis
- Keywords
- Disc disease, Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Vejle Hospital, Aarhus University Hospital, Copenhagen University Hospital, Denmark
- Study start
- Jan 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Jan 2012 (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.
Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery.
The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.
Detailed description
Major spine surgery is usually associated with high postoperative pain scores and opioid requirements. Epidural analgesia has been reported to be an effective and safe method to control postoperative pain after spinal instrumentation surgery, but the overall effects of pain management on postoperative length of stay and recovery remains debatable.
However, in a multimodal approach, including multimodal non-opioid analgesia to control postoperative pathophysiology and rehabilitation, complications and hospital stay have been reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and abdominal surgery and other procedures, when combined with an enhanced recovery program.
The aim of the study is to assess the effect and safety of a combined analgesic regimen consisting of local anesthetic, intra-operative and post-operative continuous epidural analgesia and a single dose ketorolac together with a fast track rehabilitation program after 360 degree lumbar fusion for degenerative disc disease and spondylolisthesis < 2
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment program | Experimental | Drug: Postoperative epidural morphine, Drug: Local anaesthesiaThe control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed. The intervention group received the same training program but with a faster program plus a higher intensity exercise-training program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Degenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels.
Key exclusion criteria (1 listed)
- Previous fusion, metabolic bone disease, severe comorbidity or psychological instability.
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 |
|---|---|---|
| Postoperative epidural morphineAlso: Convalescence after lumbar fusionThe control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program. | Drug | Conservative treatment program |
| Local anaesthesiaAlso: Convalescence after lumbar fusion.Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously. | Drug | Conservative treatment program |
Primary outcome
Multimodal management of lumbar fusion
Time frame: Two years
Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index
1 secondary outcome
Multimodal management of lumbar fusion
Time frame: Two years
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 28 May 2015.
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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.
Sten Rasmussen, M.D. principal investigator
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
David S. Krum-Moeller, M.D. study chair
Department of Orthopaedic Surgery, Vejle and Give Hospital
Lene R. Lauridsen study chair
Department of Orthopaedic Surgery, Vejle and Give Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative epidural morphine and Local anaesthesia in people with Degenerative Spondylolisthesis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 1 inclusion and 1 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 28 May 2015. 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 Denmark. 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 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?
Multimodal management of lumbar fusion (time frame: Two years). 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 28 May 2015; AzTrials last refreshed its copy on 29 Oct 2026.