Low Back PainNCT00644111
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
A study testing Bupivicaine, Hydromorphone in people with Low Back Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Bupivicaine, Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Jul 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo minimally invasive lumbar decompression and fusion at the Toronto Western Hospital
- both genders
- ASA I to III
- BMI less than 35
Who cannot join
- refuses treatment randomization
- inability to give informed consent
- language barrier
- local anesthetic allergy
- allergy to shellfish or eggs
- bleeding diathesis
Show all 12Show fewer
- sickle cell disease or trait
- pregnancy
- drug addiction
- psychiatric history
- severe intercurrent illness (ASA IV or V)
- patients requiring anesthesia of other surgical sites
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. MIS fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). Epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. In order to fully maximize the benefits of an MIS technique, early post-operative analgesia/pain must be improved. The aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized trial involving 32 patients undergoing MIS decompression and fusion with half the study group receiving active epidural and IV-PCA and the other half receiving epidural placebo and IV-PCA.
The hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after MIS decompression and fusion.
- Conditions
- Low Back Pain
- Being tested
- Bupivicaine, Hydromorphone, Saline Placebo
- Keywords
- Minimally Invasive Decompression and Fusion, Postoperative analgesia, Epidural, Lumbar
- 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.
Bupivicaine, HydromorphoneDrug
0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2
Saline PlaceboDrug
Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Control group receiving saline placebo through an epidural catheter Receives: Drug: Saline Placebo |
| 2 | Active comparator | Experimental group receiving active medication through the epidural catheter Receives: Drug: Bupivicaine, Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in opioid consumption in the first 48 hours post-operatively
Measured: 48 hours
Secondary outcomes (4)
Reduction in VRS pain scores
Measured: Duration of Admission
Reduction in total opioid consumption
Measured: Duration of Admission
Reduction in opioid related side effects
Measured: Duration of Admission
Reduction in time to discharge
Measured: Duration of Admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Choi, MD, Principal investigator, Resident Physician, Deparment of Anesthesia, University of TorontoRichard T Brull, MD, Principal investigator, Department of Anesthesia, University Health Network, Toronto Western HospitalYoga R Rampersaud, MD, Principal investigator, Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western HospitalVincent WS Chan, MD, Study director, Department of Anesthesia, University Health Network, Toronto Western HospitalPaul S Tumber, MD, Study director, Department of Anesthesia, University Health Network, Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644111
- Sponsor's protocol ID
- UHN 07-0736-A
- Status last verified
- Feb 2013
- First submitted
- 20 Mar 2008
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kundra P, Gurnani A, Bhattacharya A. Preemptive epidural morphine for postoperative pain relief after lumbar laminectomy. Anesth Analg. 1997 Jul;85(1):135-8. doi: 10.1097/00000539-199707000-00024.
PubMed 9212136Schenk MR, Putzier M, Kugler B, Tohtz S, Voigt K, Schink T, Kox WJ, Spies C, Volk T. Postoperative analgesia after major spine surgery: patient-controlled epidural analgesia versus patient-controlled intravenous analgesia. Anesth Analg. 2006 Nov;103(5):1311-7. doi: 10.1213/01.ane/0000247966.49492.72.
PubMed 17056975Turner A, Lee J, Mitchell R, Berman J, Edge G, Fennelly M. The efficacy of surgically placed epidural catheters for analgesia after posterior spinal surgery. Anaesthesia. 2000 Apr;55(4):370-3. doi: 10.1046/j.1365-2044.2000.01117.x.
PubMed 10781125Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.
PubMed 11965272Gottschalk 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 15220788Blumenthal S, Min K, Nadig M, Borgeat A. Double epidural catheter with ropivacaine versus intravenous morphine: a comparison for postoperative analgesia after scoliosis correction surgery. Anesthesiology. 2005 Jan;102(1):175-80. doi: 10.1097/00000542-200501000-00026.
PubMed 15618801Ray CD, Bagley R. Indwelling epidural morphine for control of post-lumbar spinal surgery pain. Neurosurgery. 1983 Oct;13(4):388-93. doi: 10.1227/00006123-198310000-00007.
PubMed 6633831Cohen BE, Hartman MB, Wade JT, Miller JS, Gilbert R, Chapman TM. Postoperative pain control after lumbar spine fusion. Patient-controlled analgesia versus continuous epidural analgesia. Spine (Phila Pa 1976). 1997 Aug 15;22(16):1892-6; discussion 1896-7. doi: 10.1097/00007632-199708150-00016.
PubMed 9280026Fisher CG, Belanger L, Gofton EG, Umedaly HS, Noonan VK, Abramson C, Wing PC, Brown J, Dvorak MF. Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion. Spine (Phila Pa 1976). 2003 Apr 15;28(8):739-43.
PubMed 12698113Park Y, Ha JW. Comparison of one-level posterior lumbar interbody fusion performed with a minimally invasive approach or a traditional open approach. Spine (Phila Pa 1976). 2007 Mar 1;32(5):537-43. doi: 10.1097/01.brs.0000256473.49791.f4.
PubMed 17334287Podichetty VK, Spears J, Isaacs RE, Booher J, Biscup RS. Complications associated with minimally invasive decompression for lumbar spinal stenosis. J Spinal Disord Tech. 2006 May;19(3):161-6. doi: 10.1097/01.bsd.0000188663.46391.73.
PubMed 16770211Sandhu NS, Sidhu DS, Capan LM. The cost comparison of infraclavicular brachial plexus block by nerve stimulator and ultrasound guidance. Anesth Analg. 2004 Jan;98(1):267-268. doi: 10.1213/01.ANE.0000077685.55641.7C. No abstract available.
PubMed 14693638Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.
PubMed 17377115Foley KM. The treatment of cancer pain. N Engl J Med. 1985 Jul 11;313(2):84-95. doi: 10.1056/NEJM198507113130205.
PubMed 2582259Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
PubMed 6240632
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
- ClinicalTrials.gov ID
- NCT00644111
- Acronym / sponsor ID
- UHN 07-0736-A
- Conditions
- Low Back Pain
- Keywords
- Minimally Invasive Decompression and Fusion, Postoperative analgesia, Epidural, Lumbar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Mar 2008 (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.
Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. MIS fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). Epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. In order to fully maximize the benefits of an MIS technique, early post-operative analgesia/pain must be improved. The aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized trial involving 32 patients undergoing MIS decompression and fusion with half the study group receiving active epidural and IV-PCA and the other half receiving epidural placebo and IV-PCA.
The hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after MIS decompression and fusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Saline PlaceboControl group receiving saline placebo through an epidural catheter |
| 2 | Active comparator | Drug: Bupivicaine, HydromorphoneExperimental group receiving active medication through the epidural catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients scheduled to undergo minimally invasive lumbar decompression and fusion at the Toronto Western Hospital
- both genders
- ASA I to III
- BMI less than 35
Key exclusion criteria (12 listed)
- refuses treatment randomization
- inability to give informed consent
- language barrier
- local anesthetic allergy
- allergy to shellfish or eggs
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 |
|---|---|---|
| Bupivicaine, Hydromorphone0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2 | Drug | 2 |
| Saline PlaceboSaline placebo continuous epidural infusion of 6 mL per hour in Arm 1 | Drug | 1 |
Primary outcome
Reduction in opioid consumption in the first 48 hours post-operatively
Time frame: 48 hours
4 secondary outcomes
Reduction in VRS pain scores
Time frame: Duration of Admission
Reduction in total opioid consumption
Time frame: Duration of Admission
Reduction in opioid related side effects
Time frame: Duration of Admission
Reduction in time to discharge
Time frame: Duration of Admission
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 13 Feb 2013.
- Background: PubMed 9212136Kundra P, Gurnani A, Bhattacharya A. Preemptive epidural morphine for postoperative pain relief after lumbar laminectomy. Anesth Analg. 1997 Jul;85(1):135-8. doi: 10.1097/00000539-199707000-00024.
- Background: PubMed 17056975Schenk MR, Putzier M, Kugler B, Tohtz S, Voigt K, Schink T, Kox WJ, Spies C, Volk T. Postoperative analgesia after major spine surgery: patient-controlled epidural analgesia versus patient-controlled intravenous analgesia. Anesth Analg. 2006 Nov;103(5):1311-7. doi: 10.1213/01.ane/0000247966.49492.72.
- Background: PubMed 10781125Turner A, Lee J, Mitchell R, Berman J, Edge G, Fennelly M. The efficacy of surgically placed epidural catheters for analgesia after posterior spinal surgery. Anaesthesia. 2000 Apr;55(4):370-3. doi: 10.1046/j.1365-2044.2000.01117.x.
- Background: PubMed 11965272Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.
- 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 15618801Blumenthal S, Min K, Nadig M, Borgeat A. Double epidural catheter with ropivacaine versus intravenous morphine: a comparison for postoperative analgesia after scoliosis correction surgery. Anesthesiology. 2005 Jan;102(1):175-80. doi: 10.1097/00000542-200501000-00026.
- Background: PubMed 6633831Ray CD, Bagley R. Indwelling epidural morphine for control of post-lumbar spinal surgery pain. Neurosurgery. 1983 Oct;13(4):388-93. doi: 10.1227/00006123-198310000-00007.
- Background: PubMed 9280026Cohen BE, Hartman MB, Wade JT, Miller JS, Gilbert R, Chapman TM. Postoperative pain control after lumbar spine fusion. Patient-controlled analgesia versus continuous epidural analgesia. Spine (Phila Pa 1976). 1997 Aug 15;22(16):1892-6; discussion 1896-7. doi: 10.1097/00007632-199708150-00016.
- Background: PubMed 12698113Fisher CG, Belanger L, Gofton EG, Umedaly HS, Noonan VK, Abramson C, Wing PC, Brown J, Dvorak MF. Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion. Spine (Phila Pa 1976). 2003 Apr 15;28(8):739-43.
- Background: PubMed 17334287Park Y, Ha JW. Comparison of one-level posterior lumbar interbody fusion performed with a minimally invasive approach or a traditional open approach. Spine (Phila Pa 1976). 2007 Mar 1;32(5):537-43. doi: 10.1097/01.brs.0000256473.49791.f4.
- Background: PubMed 16770211Podichetty VK, Spears J, Isaacs RE, Booher J, Biscup RS. Complications associated with minimally invasive decompression for lumbar spinal stenosis. J Spinal Disord Tech. 2006 May;19(3):161-6. doi: 10.1097/01.bsd.0000188663.46391.73.
- Background: PubMed 14693638Sandhu NS, Sidhu DS, Capan LM. The cost comparison of infraclavicular brachial plexus block by nerve stimulator and ultrasound guidance. Anesth Analg. 2004 Jan;98(1):267-268. doi: 10.1213/01.ANE.0000077685.55641.7C. No abstract available.
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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.
Stephen Choi, MD principal investigator
Resident Physician, Deparment of Anesthesia, University of Toronto
Richard T Brull, MD principal investigator
Department of Anesthesia, University Health Network, Toronto Western Hospital
Yoga R Rampersaud, MD principal investigator
Deparment of Surgery, Division of Orthopedics, University Health Network, Toronto Western 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 Bupivicaine, Hydromorphone in people with Low Back Pain, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 12 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 13 Feb 2013. 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 Canada. 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.
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?
Reduction in opioid consumption in the first 48 hours post-operatively (time frame: 48 hours). 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 NCT00644111, which also lists 16 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 13 Feb 2013.