Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

NCT01986946 | Terminated Phase 3 Results

• 1 other identifier: Pro00041252
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
2. 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.

Conditions

Lumbar Spine Fusion; Pain; Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative day 1

Secondary Outcomes (12)

• Patient Satisfaction With Perioperative Analgesia

  Post-operative Day 1

• Patient Satisfaction With Perioperative Analgesia

  6-Week Follow up Visit

• Patient Satisfaction With Overall Care

  6-Week Follow up Visit

• Number of Participants With Events of Special Interest

  Post-operative Day 30

• Number of Participants With Adverse Events Related to the Study

  6-week Follow up Visit

Study Arms (2)

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.

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.

Other: Epidural Catheter - Dilaudid

Interventions

Epidural Catheter - Dilaudid OTHER

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.

Epidural Catheter

Dilaudid DRUG

Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).

Intravenous opioids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (7)

• 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.

  PMID: 14612482 BACKGROUND

• 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.

  PMID: 22486142 BACKGROUND

• 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.

  PMID: 15125846 BACKGROUND

• 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.

  PMID: 9280026 BACKGROUND

• 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.

  PMID: 15644759 BACKGROUND

• 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.

  PMID: 16261108 BACKGROUND

• 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.

  PMID: 22850657 BACKGROUND

MeSH Terms

Conditions

Pain; Back Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Erin Manning
• Organization: Duke University Hospital

erin.manning@duke.edu

919-681-3551

Study Officials

• Erin L Manning, MD/PhD

  Duke University Hospital Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

• Carlos Bagley, MD

  Duke University Hospital Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: November 19, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: November 11, 2016

Record last verified: 2017-01

Locations

US (1)