Clinical trial NCT01986946: Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
Official title: A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lumbar Spine Fusion
Pain
Back Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Patient Satisfaction With Perioperative Analgesia
timeFrame: Post-operative Day 1
measure: Patient Satisfaction With Perioperative Analgesia
timeFrame: 6-Week Follow up Visit
measure: Patient Satisfaction With Overall Care
timeFrame: 6-Week Follow up Visit
measure: Number of Participants With Events of Special Interest
timeFrame: Post-operative Day 30
measure: Number of Participants With Adverse Events Related to the Study
timeFrame: 6-week Follow up Visit
measure: Total Post-operative Opioid Consumption
timeFrame: during hospitalization (approximately 3-8 days)
measure: Number of Participants Experiencing Delirium
timeFrame: Post-operative Day 1
measure: Number of Participants Experiencing Delirium
timeFrame: Post-operative Day 2
measure: Number of Participants Experiencing Delirium
timeFrame: Post-operative Day 3
measure: Number of Participants Readmitted to Hospital Within 30 Days of Surgery
timeFrame: Post-operative Day 30
measure: Length of Hospital Stay
timeFrame: during hospitalization (approximately 3-8 days)
measure: Wound Infection Rates
timeFrame: during hospitalization (approximately 3-8 days)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University Hospital Department of Anesthesiology
name: Erin L Manning, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Hospital Department of Neurosurgery
name: Carlos Bagley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.