Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01986946
• Other study ID #: Pro00041252
• Status: Terminated
• Phase: Phase 3
• First received: January 3, 2013
• Last updated: February 2, 2016
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Lumbar Spine Fusion
• Pain

Intervention

Other:
• Epidural Catheter - Dilaudid
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.

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

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain as assessed by Visual Analogue Scale		Baseline	No
Primary	Post-operative pain as assessed by Visual Analogue Scale		Postoperative day 1	No
Primary	Post-operative pain as assessed by Visual Analogue Scale		Postoperative day 2	No
Primary	Post-operative pain as assessed by Visual Analogue Scale		Postoperative day 3	No
Primary	Post-operative pain as assessed by Visual Analogue Scale		Postoperative week 6	No
Secondary	Assessing change in patient functional status with regards to depression, anxiety, and pain	Hospital Anxiety and Depression Score, McGill Short-Form Pain Questionnaire, Oswestry Disability Index, and Short Form-12.	Patients will be assessed at baseline and at 6 week post-operative surgical follow-up visit utilizing a series of previously validated study forms detailed in description.	No
Secondary	Patient satisfaction with peri-operative care	Patients will be assessed for satisfaction with their peri-operative care 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.	Recovery room - 6 hours post-operatively	No
Secondary	Patient satisfaction with peri-operative care	Patients will be assessed for satisfaction with their peri-operative care 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.	Post-operative Day 1	No
Secondary	Patient satisfaction with peri-operative care	Patients will be assessed for satisfaction with their peri-operative care 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.	Post-operative Day 2	No
Secondary	Patient satisfaction with peri-operative care	Patients will be assessed for satisfaction with their peri-operative care 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.	Post-operative Day 3	No
Secondary	Patient satisfaction with peri-operative care	Patients will be assessed for satisfaction with their peri-operative care 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.	6 Week Follow up Visit	No
Secondary	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.	Recovery Room - 6 hours after surgery	No
Secondary	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.	Post-operative Day 1	No
Secondary	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.	Post-operative Day 2	No
Secondary	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.	Post-operative Day 3	No
Secondary	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.	6-Week Follow up Visit	No
Secondary	Number of participants with adverse events	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.	Receovery Room - 6 hours post-operatively	Yes
Secondary	Number of participants with adverse events	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.	Post-operative Day 1	Yes
Secondary	Number of participants with adverse events	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.	Post-operative Day 2	Yes
Secondary	Number of participants with adverse events	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.	Post-operative Day 3	Yes
Secondary	Number of participants with adverse events	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.	6-week Follow up Visit	Yes