Pain, PostoperativePhase 4NCT03035656
Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
A Phase 4 study testing Ropivacaine and Saline in people with Pain, Postoperative, run by Horizon Health Network.
Trial summary
The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS)… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Mar 2022
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre
Who cannot join
- History of severe respiratory, renal or hepatic disease
- Previous spine surgery
- Known allergy to local anaesthesia
- Those who experience dural tear during operative procedure
Trial locations and contacts
No sites are listed yet.
About this study
The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.
Read the detailed description
This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine, Saline
- Keywords
- Pain, analgesic, spinal fusion
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Administration of Ropivaciane via epidural injection intra-operatively
SalineOther
Administration of saline via epidural injection intra-operatively
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Administration of epidural Ropivaciane Receives: Drug: Ropivacaine |
| Control | Placebo comparator | Administration of saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.
Measured: Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively
Secondary outcomes (3)
Change in Disability
Measurement of disability attributed to "back problem" using the validated Oswestry Disability Index (ODI).
Measured: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
Change in General Health
Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12)
Measured: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
Change in Medication Use
Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital.
Measured: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. neil Manson, Horizon Health Network
- Investigators
- Neil A Manson, MD FRCSC, Principal investigator, Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of SurgeryEdward P Abraham, MD FRCSC, Principal investigator, Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035656
- Sponsor's protocol ID
- 2016-2380
- Status last verified
- Feb 2019
- First submitted
- 19 Jan 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Study results will be made available following data analysis.
Publications
Raw DA, Beattie JK, Hunter JM. Anaesthesia for spinal surgery in adults. Br J Anaesth. 2003 Dec;91(6):886-904. doi: 10.1093/bja/aeg253.
PubMed 14633762Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
PubMed 14667752Gessler F, Mutlak H, Tizi K, Senft C, Setzer M, Seifert V, Weise L. Postoperative patient-controlled epidural analgesia in patients with spondylodiscitis and posterior spinal fusion surgery. J Neurosurg Spine. 2016 Jun;24(6):965-70. doi: 10.3171/2015.8.SPINE15415. Epub 2016 Feb 5.
PubMed 26849711Hallivis R, Derksen TA, Meyr AJ. Peri-operative pain management. Clin Podiatr Med Surg. 2008 Jul;25(3):443-63; vii. doi: 10.1016/j.cpm.2008.02.006.
PubMed 18486854Sandkuhler J. Fear the pain. Lancet. 2002 Aug 10;360(9331):426. doi: 10.1016/S0140-6736(02)09683-6. No abstract available.
PubMed 12241712Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.
PubMed 10376632Breivik H. Postoperative pain management: why is it difficult to show that it improves outcome? Eur J Anaesthesiol. 1998 Nov;15(6):748-51. doi: 10.1097/00003643-199811000-00022.
PubMed 9884866Gottschalk 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 15220788Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.
PubMed 23467861Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.
PubMed 8706199Kluba T, Hofmann F, Bredanger S, Blumenstock G, Niemeyer T. Efficacy of post-operative analgesia after posterior lumbar instrumented fusion for degenerative disc disease: a prospective randomized comparison of epidural catheter and intravenous administration of analgesics. Orthop Rev (Pavia). 2010 Mar 20;2(1):e9. doi: 10.4081/or.2010.e9.
PubMed 21808704Liu SS, Carpenter RL, Mackey DC, Thirlby RC, Rupp SM, Shine TS, Feinglass NG, Metzger PP, Fulmer JT, Smith SL. Effects of perioperative analgesic technique on rate of recovery after colon surgery. Anesthesiology. 1995 Oct;83(4):757-65. doi: 10.1097/00000542-199510000-00015.
PubMed 7574055Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PubMed 9175983Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative pain treatment. Anesth Analg. 1993 Nov;77(5):1048-56. doi: 10.1213/00000539-199311000-00030. No abstract available.
PubMed 8105724
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion
- ClinicalTrials.gov ID
- NCT03035656
- Acronym / sponsor ID
- 2016-2380
- Conditions
- Pain, Postoperative
- Keywords
- Pain, analgesic, spinal fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 30 Jan 2017 (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.
The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.
Detailed description
This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: RopivacaineAdministration of epidural Ropivaciane |
| Control | Placebo comparator | Other: SalineAdministration of saline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre
Key exclusion criteria (4 listed)
- History of severe respiratory, renal or hepatic disease
- Previous spine surgery
- Known allergy to local anaesthesia
- Those who experience dural tear during operative procedure
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 |
|---|---|---|
| RopivacaineAdministration of Ropivaciane via epidural injection intra-operatively | Drug | Experimental |
| SalineAdministration of saline via epidural injection intra-operatively | Other | Control |
Primary outcome
Change in Pain
Time frame: Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively
Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.
3 secondary outcomes
Change in Disability
Time frame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
Change in General Health
Time frame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
Change in Medication Use
Time frame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Background: PubMed 14633762Raw DA, Beattie JK, Hunter JM. Anaesthesia for spinal surgery in adults. Br J Anaesth. 2003 Dec;91(6):886-904. doi: 10.1093/bja/aeg253.
- Background: PubMed 14667752Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
- Background: PubMed 26849711Gessler F, Mutlak H, Tizi K, Senft C, Setzer M, Seifert V, Weise L. Postoperative patient-controlled epidural analgesia in patients with spondylodiscitis and posterior spinal fusion surgery. J Neurosurg Spine. 2016 Jun;24(6):965-70. doi: 10.3171/2015.8.SPINE15415. Epub 2016 Feb 5.
- Background: PubMed 18486854Hallivis R, Derksen TA, Meyr AJ. Peri-operative pain management. Clin Podiatr Med Surg. 2008 Jul;25(3):443-63; vii. doi: 10.1016/j.cpm.2008.02.006.
- Background: PubMed 12241712Sandkuhler J. Fear the pain. Lancet. 2002 Aug 10;360(9331):426. doi: 10.1016/S0140-6736(02)09683-6. No abstract available.
- Background: PubMed 10376632Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.
- Background: PubMed 9884866Breivik H. Postoperative pain management: why is it difficult to show that it improves outcome? Eur J Anaesthesiol. 1998 Nov;15(6):748-51. doi: 10.1097/00003643-199811000-00022.
- 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 23467861Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.
- Background: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Background: PubMed 8706199Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.
- Background: PubMed 21808704Kluba T, Hofmann F, Bredanger S, Blumenstock G, Niemeyer T. Efficacy of post-operative analgesia after posterior lumbar instrumented fusion for degenerative disc disease: a prospective randomized comparison of epidural catheter and intravenous administration of analgesics. Orthop Rev (Pavia). 2010 Mar 20;2(1):e9. doi: 10.4081/or.2010.e9.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Study results will be made available following data analysis.
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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.
Neil A Manson, MD FRCSC principal investigator
Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
Edward P Abraham, MD FRCSC principal investigator
Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Saline in people with Pain, Postoperative, run by Horizon Health Network.
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 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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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 Erin E Bigney, BA MA (506 648 6028, cescresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively). 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 NCT03035656, which also lists 29 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 21 Feb 2019.