Trial Outcomes & Findings for Enhanced Recovery After Spine Surgery (NCT NCT02949518)
NCT ID: NCT02949518
Last Updated: 2020-07-28
Results Overview
The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Postoperative Day 3
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Enhanced Recovery Pathway
An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.
|
Usual Care
Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhanced Recovery After Spine Surgery
Baseline characteristics by cohort
| Measure |
Enhanced Recovery Pathway
n=25 Participants
An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution.
|
Usual Care
n=26 Participants
Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 18.1 • n=99 Participants
|
54.2 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
54.5 years
STANDARD_DEVIATION 15.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
ASA Level
ASA I
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
ASA Level
ASA II
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
ASA Level
ASA III
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 4.2 • n=99 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 5.3 • n=107 Participants
|
28.26 kg/m^2
STANDARD_DEVIATION 4.89 • n=206 Participants
|
|
Total Anesthesia Time
|
269 minutes
STANDARD_DEVIATION 57 • n=99 Participants
|
268.5 minutes
STANDARD_DEVIATION 63.8 • n=107 Participants
|
268.76 minutes
STANDARD_DEVIATION 59.91 • n=206 Participants
|
|
Total Surgery Time
|
183.2 minutes
STANDARD_DEVIATION 54 • n=99 Participants
|
192.3 minutes
STANDARD_DEVIATION 62.4 • n=107 Participants
|
187.84 minutes
STANDARD_DEVIATION 58.0 • n=206 Participants
|
|
Surgery Fusion Level
Fusion Level I
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Surgery Fusion Level
Fusion Level II
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 3The Quality of Recovery 40 (QoR40) is a 40-item questionnaire which assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support and pain. The QoR40 has been validated for both clinical and research use. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=22 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=25 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Patient Score on QoR40 Inventory.
|
179.4 scores on a scale
Standard Deviation 13.79
|
170.3 scores on a scale
Standard Deviation 15.49
|
SECONDARY outcome
Timeframe: Postoperative Day 5Population: One patient did not meet physical therapy goals
Measured in days after surgery (in half-day increments).
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.
Length of Stay
|
2.8 days
Interval 2.1 to 3.7
|
3.1 days
Interval 2.8 to 4.8
|
|
Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.
Time to meet physical therapy goals
|
1.4 days
Interval 1.0 to 2.4
|
1.9 days
Interval 1.8 to 2.9
|
SECONDARY outcome
Timeframe: 48 hours after surgeryPopulation: Patients who were discharged between the 24-48 hour time mark did not have data collected.
Measured in morphine equivalents daily.
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=24 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Pain Control: Opioid Consumption.
0-24 Hours
|
61.8 morphine equivalents daily
Interval 25.6 to 103.3
|
133.2 morphine equivalents daily
Interval 39.5 to 218.3
|
|
Pain Control: Opioid Consumption.
24-48 Hours
|
30 morphine equivalents daily
Interval 20.0 to 97.5
|
75 morphine equivalents daily
Interval 28.0 to 120.0
|
SECONDARY outcome
Timeframe: Postoperative Day 1Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=24 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=23 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1
|
3 units on a scale
Interval 0.5 to 3.0
|
4 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Postoperative Day 1Measured in hours
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Time to Post-operative Oral Intake.
|
5.1 hours
Interval 2.9 to 7.7
|
7.9 hours
Interval 5.5 to 13.5
|
SECONDARY outcome
Timeframe: Postoperative Day 5If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Number of Participants With Post-operative Nausea, Vomiting and Ileus
Nasea
|
8 Participants
|
13 Participants
|
|
Number of Participants With Post-operative Nausea, Vomiting and Ileus
Vomiting
|
3 Participants
|
2 Participants
|
|
Number of Participants With Post-operative Nausea, Vomiting and Ileus
Ileus
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Postoperative Days 0, 1, and 3Population: Patients who were discharged before Postoperative Day 3 did not have data collected.
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=25 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
Postoperative Day 1
|
5 pg/mL
Interval 2.5 to 7.0
|
5 pg/mL
Interval 2.5 to 8.0
|
|
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
Postoperative Day 3
|
8 pg/mL
Interval 6.0 to 19.0
|
8 pg/mL
Interval 6.0 to 21.0
|
|
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
Postoperative Day 0
|
2.5 pg/mL
Interval 2.5 to 5.0
|
2.5 pg/mL
Interval 2.5 to 5.0
|
SECONDARY outcome
Timeframe: Postoperative Days 0, 1, and 3Population: Patients who were discharged before Postoperative Day 3 did not have data collected.
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
Postoperative Day 0
|
6.3 mcg/dl
Interval 2.4 to 7.9
|
5.4 mcg/dl
Interval 2.2 to 14.0
|
|
Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
Postoperative Day 1
|
0.5 mcg/dl
Interval 0.5 to 0.5
|
0.5 mcg/dl
Interval 0.5 to 1.5
|
|
Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
Postoperative Day 3
|
8.3 mcg/dl
Interval 3.1 to 10.6
|
8.9 mcg/dl
Interval 6.9 to 13.9
|
SECONDARY outcome
Timeframe: Postoperative Days 0, 1, and 3Population: Patients discharged before postoperative day 3 did not have data collected.
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
Postoperative Day 0
|
0.4 mg/dL
Interval 0.4 to 0.7
|
0.4 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
Postoperative Day 1
|
1.6 mg/dL
Interval 0.9 to 2.5
|
1.6 mg/dL
Interval 1.1 to 2.2
|
|
Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
Postoperative Day 3
|
6.1 mg/dL
Interval 3.8 to 15.7
|
15.9 mg/dL
Interval 6.6 to 19.7
|
SECONDARY outcome
Timeframe: Postoperative Days 0, 1, and 3Population: Patients discharged before postoperative day 3 did not have data collected.
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=25 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
Postoperative Day 0
|
8 uIU/mL
Interval 5.0 to 11.0
|
10 uIU/mL
Interval 7.0 to 15.0
|
|
Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
Postoperative Day 1
|
15 uIU/mL
Interval 10.0 to 28.0
|
14 uIU/mL
Interval 8.0 to 20.0
|
|
Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
Postoperative Day 3
|
18 uIU/mL
Interval 13.0 to 46.0
|
15.5 uIU/mL
Interval 6.0 to 26.0
|
SECONDARY outcome
Timeframe: Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge.
Outcome measures
| Measure |
Enhanced Recovery Pathway (ERP) for Spine
n=25 Participants
he study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
|
Usual Care
n=26 Participants
anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment
|
|---|---|---|
|
Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE
DVT/PE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE
Delirium/Confusion
|
1 Participants
|
2 Participants
|
|
Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE
Infection
|
1 Participants
|
0 Participants
|
Adverse Events
Enhanced Recovery Pathway
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place