Trial Outcomes & Findings for Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions (NCT NCT01986946)

NCT ID: NCT01986946

Last Updated: 2017-02-23

Results Overview

The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 17 participants
• Primary outcome timeframe: Postoperative day 1
• Results posted on: 2017-02-23

Participant Flow

17 participants consented in the study, 3 participants were not randomized in the study due to not having the surgery.

Participant milestones

Measure	Intravenous Opioids 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 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.
Overall Study STARTED	5	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

Baseline characteristics by cohort

Measure	Intravenous Opioids n=5 Participants 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 n=9 Participants 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 n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Gender Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative day 1

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

The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

Outcome measures

Measure	Intravenous Opioids n=3 Participants 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 n=8 Participants 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.
Post-operative Pain as Assessed by Visual Analogue Scale (VAS)	36.33 units on a scale Standard Deviation 26.66	40.63 units on a scale Standard Deviation 29.09

SECONDARY outcome

Timeframe: Post-operative Day 1

Population: Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment.

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).

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=7 Participants 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.
Patient Satisfaction With Perioperative Analgesia	2.4 units on a scale Standard Deviation 1.02	1.29 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6-Week Follow up Visit

Population: Participants who completed the patient satisfaction scale at the 6 week follow up visit.

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).

Outcome measures

Measure	Intravenous Opioids n=3 Participants 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 n=8 Participants 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.
Patient Satisfaction With Perioperative Analgesia	2 units on a scale Standard Deviation 0.82	1.5 units on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 6-Week Follow up Visit

Population: Participants who completed the patient satisfaction scale at the 6 week follow up visit.

Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).

Outcome measures

Measure	Intravenous Opioids n=3 Participants 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 n=8 Participants 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.
Patient Satisfaction With Overall Care	1 units on a scale Standard Deviation 0	1.5 units on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Post-operative Day 30

Population: Data not collected

Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6-week Follow up Visit

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.

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=9 Participants 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.
Number of Participants With Adverse Events Related to the Study	0 participants	0 participants

SECONDARY outcome

Timeframe: during hospitalization (approximately 3-8 days)

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=9 Participants 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 Post-operative Opioid Consumption	438.52 oral morphine equivilant (mg) Standard Deviation 292.87	410.42 oral morphine equivilant (mg) Standard Deviation 501.09

SECONDARY outcome

Timeframe: Post-operative Day 1

Population: Only participants who had assessment for delirium are include in the analysis.

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=8 Participants 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.
Number of Participants Experiencing Delirium	0 participants	0 participants

SECONDARY outcome

Timeframe: Post-operative Day 2

Population: Participants who were evaluated for Delirium on Day 2

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=6 Participants 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.
Number of Participants Experiencing Delirium	0 participants	0 participants

SECONDARY outcome

Timeframe: Post-operative Day 3

Population: Participants who were evaluated for Delirium on Day 3

Outcome measures

Measure	Intravenous Opioids n=1 Participants 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 n=5 Participants 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.
Number of Participants Experiencing Delirium	0 participants	0 participants

SECONDARY outcome

Timeframe: Post-operative Day 30

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=9 Participants 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.
Number of Participants Readmitted to Hospital Within 30 Days of Surgery	0 participants	0 participants

SECONDARY outcome

Timeframe: during hospitalization (approximately 3-8 days)

Outcome measures

Measure	Intravenous Opioids n=5 Participants 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 n=9 Participants 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.
Length of Hospital Stay	4.4 days Standard Deviation 1.02	4.33 days Standard Deviation 1.41

SECONDARY outcome

Timeframe: during hospitalization (approximately 3-8 days)

Population: Data not collected

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Opioids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural Catheter

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous Opioids n=5 participants at risk 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 n=9 participants at risk 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.
Surgical and medical procedures Hypotension	0.00% 0/5	11.1% 1/9

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin Manning

Duke University Hospital

Phone: 919-681-3551

Email: erin.manning@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place