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Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986946
Recruitment Status : Terminated (Lack of recruitment.)
First Posted : November 19, 2013
Results First Posted : November 11, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lumbar Spine Fusion
Pain
Back Pain
Interventions Other: Epidural Catheter - Dilaudid
Drug: Dilaudid
Enrollment 17
Recruitment Details 17 participants consented in the study, 3 participants were not randomized in the study due to not having the surgery.
Pre-assignment Details  
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description

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.

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

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.

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.

Period Title: Overall Study
Started 5 9
Completed 5 9
Not Completed 0 0
Arm/Group Title Intravenous Opioids Epidural Catheter Total
Hide Arm/Group Description

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.

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

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. Total of all reporting groups
Overall Number of Baseline Participants 5 9 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 9 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
3
  33.3%
6
  42.9%
>=65 years
2
  40.0%
6
  66.7%
8
  57.1%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 9 participants 14 participants
Female
4
  80.0%
8
  88.9%
12
  85.7%
Male
1
  20.0%
1
  11.1%
2
  14.3%
1.Primary Outcome
Title Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
Hide Description The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant that provided a VAS score at postoperative day 1 time point.
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
36.33  (26.66) 40.63  (29.09)
2.Secondary Outcome
Title Patient Satisfaction With Perioperative Analgesia
Hide Description 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).
Time Frame Post-operative Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment.
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (1.02) 1.29  (0.7)
3.Secondary Outcome
Title Patient Satisfaction With Perioperative Analgesia
Hide Description 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).
Time Frame 6-Week Follow up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the patient satisfaction scale at the 6 week follow up visit.
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
2  (0.82) 1.5  (0.71)
4.Secondary Outcome
Title Patient Satisfaction With Overall Care
Hide Description Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Time Frame 6-Week Follow up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the patient satisfaction scale at the 6 week follow up visit.
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
1  (0) 1.5  (0.71)
5.Secondary Outcome
Title Number of Participants With Events of Special Interest
Hide Description Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
Time Frame Post-operative Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Adverse Events Related to the Study
Hide Description 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.
Time Frame 6-week Follow up Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 9
Measure Type: Number
Unit of Measure: participants
0 0
7.Secondary Outcome
Title Total Post-operative Opioid Consumption
Hide Description [Not Specified]
Time Frame during hospitalization (approximately 3-8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 9
Mean (Standard Deviation)
Unit of Measure: oral morphine equivilant (mg)
438.52  (292.87) 410.42  (501.09)
8.Secondary Outcome
Title Number of Participants Experiencing Delirium
Hide Description [Not Specified]
Time Frame Post-operative Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who had assessment for delirium are include in the analysis.
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 8
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Number of Participants Experiencing Delirium
Hide Description [Not Specified]
Time Frame Post-operative Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluated for Delirium on Day 2
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Number of Participants Experiencing Delirium
Hide Description [Not Specified]
Time Frame Post-operative Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluated for Delirium on Day 3
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 1 5
Measure Type: Number
Unit of Measure: participants
0 0
11.Secondary Outcome
Title Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Hide Description [Not Specified]
Time Frame Post-operative Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 9
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame during hospitalization (approximately 3-8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 5 9
Mean (Standard Deviation)
Unit of Measure: days
4.4  (1.02) 4.33  (1.41)
13.Secondary Outcome
Title Wound Infection Rates
Hide Description [Not Specified]
Time Frame during hospitalization (approximately 3-8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Opioids Epidural Catheter
Hide Arm/Group Description

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.

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

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.
All-Cause Mortality
Intravenous Opioids Epidural Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Intravenous Opioids Epidural Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   1/9 (11.11%) 
Surgical and medical procedures     
Hypotension  0/5 (0.00%)  1/9 (11.11%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Opioids Epidural Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/9 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Erin Manning
Organization: Duke University Hospital
Phone: 919-681-3551
EMail: erin.manning@duke.edu
Publications:
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01986946    
Other Study ID Numbers: Pro00041252
First Submitted: January 3, 2013
First Posted: November 19, 2013
Results First Submitted: September 23, 2016
Results First Posted: November 11, 2016
Last Update Posted: February 23, 2017