Lumbar Spine FusionPhase 3NCT01986946

Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

A Phase 3 study testing Epidural Catheter - Dilaudid and Dilaudid in people with Lumbar Spine Fusion and Pain, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lumbar Spine Fusion, Pain, Back Pain
What is being tested?: Epidural Catheter - Dilaudid and Dilaudid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Sep 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery

Who cannot join

Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
Inability to follow directions or comprehend the English language.
Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
Prisoners.
Patient refusal to provide informed consent.
Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Hospital
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study

Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.

Hypothesis:

The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

Conditions: Lumbar Spine Fusion, Pain, Back Pain
Being tested: Epidural Catheter - Dilaudid, Dilaudid
Medical subject headings: Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epidural Catheter - DilaudidOther
Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
DilaudidDrug
Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).

Study groups in NCT01986946
Study group	Role	What they receive
Intravenous opioids	Experimental	This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control. Receives: Drug: Dilaudid
Epidural Catheter	Experimental	The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery. Receives: Other: Epidural Catheter - Dilaudid

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Measured: Postoperative day 1

Secondary outcomes (12)

Patient Satisfaction With Perioperative Analgesia
Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Measured: Post-operative Day 1
Patient Satisfaction With Perioperative Analgesia
Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Measured: 6-Week Follow up Visit
Patient Satisfaction With Overall Care
Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Measured: 6-Week Follow up Visit
Number of Participants With Events of Special Interest
Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
Measured: Post-operative Day 30
Number of Participants With Adverse Events Related to the Study
Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
Measured: 6-week Follow up Visit
Total Post-operative Opioid Consumption
Measured: during hospitalization (approximately 3-8 days)
Number of Participants Experiencing Delirium
Measured: Post-operative Day 1
Number of Participants Experiencing Delirium
Measured: Post-operative Day 2
Number of Participants Experiencing Delirium
Measured: Post-operative Day 3
Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Measured: Post-operative Day 30
Length of Hospital Stay
Measured: during hospitalization (approximately 3-8 days)
Wound Infection Rates
Measured: during hospitalization (approximately 3-8 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Sep 2015

First posted19 Nov 2013 (estimated)
Study startOct 2013
Primary completionSep 2015
Study completionSep 2015

Why it stopped: Lack of recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Lumbar Spine FusionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986946
Sponsor's protocol ID: Pro00041252
Status last verified: Jan 2017
First submitted: 3 Jan 2013
Last updated: 23 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
PubMed 14612482
Abrishamkar S, Eshraghi N, Feizi A, Talakoub R, Rafiei A, Rahmani P. Analgesic effects of ketamine infusion on postoperative pain after fusion and instrumentation of the lumbar spine: a prospective randomized clinical trial. Med Arh. 2012;66(2):107-10. doi: 10.5455/medarh.2012.66.107-110.
PubMed 22486142
Sekar C, Rajasekaran S, Kannan R, Reddy S, Shetty TA, Pithwa YK. Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004 May-Jun;4(3):261-4. doi: 10.1016/j.spinee.2003.11.009.
PubMed 15125846
Cohen 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 9280026
Sucato DJ, Duey-Holtz A, Elerson E, Safavi F. Postoperative analgesia following surgical correction for adolescent idiopathic scoliosis: a comparison of continuous epidural analgesia and patient-controlled analgesia. Spine (Phila Pa 1976). 2005 Jan 15;30(2):211-7. doi: 10.1097/01.brs.0000150832.53604.64.
PubMed 15644759
Yukawa Y, Kato F, Ito K, Terashima T, Horie Y. A prospective randomized study of preemptive analgesia for postoperative pain in the patients undergoing posterior lumbar interbody fusion: continuous subcutaneous morphine, continuous epidural morphine, and diclofenac sodium. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2357-61. doi: 10.1097/01.brs.0000184377.31427.fa.
PubMed 16261108
Parker SL, Lerner J, McGirt MJ. Effect of minimally invasive technique on return to work and narcotic use following transforaminal lumbar inter-body fusion: a review. Prof Case Manag. 2012 Sep-Oct;17(5):229-35. doi: 10.1097/NCM.0b013e3182529c05.
PubMed 22850657

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis

All Lumbar Spine Fusion trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
ClinicalTrials.gov ID: NCT01986946
Acronym / sponsor ID: Pro00041252
Conditions: Lumbar Spine Fusion, Pain, Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of recruitment.
Enrolment: 17 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Oct 2013
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 19 Nov 2013 (estimated)
Results: Posted 11 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.

Hypothesis:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intravenous opioids	Experimental	Drug: DilaudidThis is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
Epidural Catheter	Experimental	Other: Epidural Catheter - DilaudidThe intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery

Key exclusion criteria (6 listed)

Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
Inability to follow directions or comprehend the English language.
Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
Prisoners.
Patient refusal to provide informed consent.

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
Epidural Catheter - DilaudidPlacement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.	Other	Epidural Catheter
DilaudidPatients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).	Drug	Intravenous opioids

Primary outcome

Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
Time frame: Postoperative day 1
The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

12 secondary outcomes

Patient Satisfaction With Perioperative Analgesia
Time frame: Post-operative Day 1
Patient Satisfaction With Perioperative Analgesia
Time frame: 6-Week Follow up Visit
Patient Satisfaction With Overall Care
Time frame: 6-Week Follow up Visit
Number of Participants With Events of Special Interest
Time frame: Post-operative Day 30
Number of Participants With Adverse Events Related to the Study
Time frame: 6-week Follow up Visit
Total Post-operative Opioid Consumption
Time frame: during hospitalization (approximately 3-8 days)
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 1
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 2
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 3
Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Time frame: Post-operative Day 30
Length of Hospital Stay
Time frame: during hospitalization (approximately 3-8 days)
Wound Infection Rates
Time frame: during hospitalization (approximately 3-8 days)

Results and safety

Results posted to the registry on 11 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous Opioids	5	5
Epidural Catheter	9	9

Primary outcome: Post-operative Pain as Assessed by Visual Analogue Scale (VAS)

Time frame: Postoperative day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Intravenous Opioids n = 3	Epidural Catheter n = 8
Value	36.33 (26.66)	40.63 (29.09)

Population analysed: Participant that provided a VAS score at postoperative day 1 time point.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous Opioids	0 of 5 (0%)	0 of 5 (0%)	Not reported
Epidural Catheter	1 of 9 (11.1%)	0 of 9 (0%)	Not reported

Limitations and caveats (from the sponsor): Enrollment was terminated when co-PI/coordinator left Duke. No surgical collaborators would enroll subjects. Low enrollment of the study significantly affected the analysis, as both study arms were expected to have 100 participants each.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14612482Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
Background: PubMed 22486142Abrishamkar S, Eshraghi N, Feizi A, Talakoub R, Rafiei A, Rahmani P. Analgesic effects of ketamine infusion on postoperative pain after fusion and instrumentation of the lumbar spine: a prospective randomized clinical trial. Med Arh. 2012;66(2):107-10. doi: 10.5455/medarh.2012.66.107-110.
Background: PubMed 15125846Sekar C, Rajasekaran S, Kannan R, Reddy S, Shetty TA, Pithwa YK. Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004 May-Jun;4(3):261-4. doi: 10.1016/j.spinee.2003.11.009.
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 15644759Sucato DJ, Duey-Holtz A, Elerson E, Safavi F. Postoperative analgesia following surgical correction for adolescent idiopathic scoliosis: a comparison of continuous epidural analgesia and patient-controlled analgesia. Spine (Phila Pa 1976). 2005 Jan 15;30(2):211-7. doi: 10.1097/01.brs.0000150832.53604.64.
Background: PubMed 16261108Yukawa Y, Kato F, Ito K, Terashima T, Horie Y. A prospective randomized study of preemptive analgesia for postoperative pain in the patients undergoing posterior lumbar interbody fusion: continuous subcutaneous morphine, continuous epidural morphine, and diclofenac sodium. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2357-61. doi: 10.1097/01.brs.0000184377.31427.fa.
Background: PubMed 22850657Parker SL, Lerner J, McGirt MJ. Effect of minimally invasive technique on return to work and narcotic use following transforaminal lumbar inter-body fusion: a review. Prof Case Manag. 2012 Sep-Oct;17(5):229-35. doi: 10.1097/NCM.0b013e3182529c05.

Related trials for Lumbar Spine Fusion

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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Recruiting
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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.

Erin L Manning, MD/PhD principal investigator

Duke University Hospital Department of Anesthesiology

Carlos Bagley, MD principal investigator

Duke University Hospital Department of Neurosurgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epidural Catheter - Dilaudid and Dilaudid in people with Lumbar Spine Fusion and Pain, run by Duke University 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 1 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 23 Feb 2017. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post-operative Pain as Assessed by Visual Analogue Scale (VAS) (time frame: Postoperative day 1). 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 NCT01986946, which also lists 7 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 23 Feb 2017.