Enhanced Recovery After SurgeryNCT02949518
Enhanced Recovery After Spine Surgery
A study testing Enhanced Recovery Pathway (ERP) for Spine in people with Enhanced Recovery After Surgery and Spine Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enhanced Recovery After Surgery, Spine Surgery
- What is being tested?
- Enhanced Recovery Pathway (ERP) for Spine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2016to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient presenting for 1 or 2 level posterior lumbar fusion.
Who cannot join
- Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate).
- Kidney disease: GFR <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012).
- Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy.
- Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease).
- Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol.
- Patients whose primary or preferred language is not English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion
Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.
- Conditions
- Enhanced Recovery After Surgery, Spine Surgery
- Being tested
- Enhanced Recovery Pathway (ERP) for Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery Pathway (ERP) for SpineOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery Pathway for Spine | Experimental | Not described Receives: Other: Enhanced Recovery Pathway (ERP) for Spine |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Score on QoR40 Inventory.
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).
Measured: Postoperative Day 3
Secondary outcomes (10)
Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.
Measured in days after surgery (in half-day increments).
Measured: Postoperative Day 5
Pain Control: Opioid Consumption.
Measured in morphine equivalents daily.
Measured: 48 hours after surgery
Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1
Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Measured: Postoperative Day 1
Time to Post-operative Oral Intake.
Measured in hours
Measured: Postoperative Day 1
Number of Participants With Post-operative Nausea, Vomiting and Ileus
If the patient ever had any of the events of nausea, vomiting, ileus by day of discharge
Measured: Postoperative Day 5
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
Measured: Postoperative Days 0, 1, and 3
Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
Measured: Postoperative Days 0, 1, and 3
Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
Measured: Postoperative Days 0, 1, and 3
Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
Measured: Postoperative Days 0, 1, and 3
Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE
Incidence of patients with event of delirium/confusion, infection, DVT/PE will be assessed for the entire hospital admission but measured at discharge.
Measured: Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start28 Nov 2016
- Primary completionFeb 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Soffin, MD, PhD, Principal investigator, Hospital for Special Surgery, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949518
- Sponsor's protocol ID
- 2016-617
- Status last verified
- Jul 2020
- First submitted
- 7 Oct 2016
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Spine Surgery: A Prospective Randomized Controlled Trial to Assess Quality of Recovery and the Biochemical Stress Response to Lumbar Fusion
- ClinicalTrials.gov ID
- NCT02949518
- Acronym / sponsor ID
- 2016-617
- Conditions
- Enhanced Recovery After Surgery, Spine Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Posted 28 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enhanced recovery pathways (ERP) after surgery have been shown to decrease length of stay and perioperative complications in a range of surgical specialties. To date, ERPs has not been studied in patients presenting for spine surgery. The investigators have recently developed an interdisciplinary pathway for spine surgery patients based on the latest available evidence and guidelines. The aim of this trial is to compare the investigators enhanced recovery pathway with conventional perioperative management in patients undergoing 1-2 level posterior lumbar fusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery Pathway for Spine | Experimental | Other: Enhanced Recovery Pathway (ERP) for Spine |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient presenting for 1 or 2 level posterior lumbar fusion.
Key exclusion criteria (6 listed)
- Cognitive impairment (baseline dementia, cognitive dysfunction or inability to consent to participate).
- Kidney disease: GFR <60 mL/min/1.73 m2 for 3 months or more, irrespective of cause (Levey et al., 2012).
- Liver disease: transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy.
- Pre-existing bowel disease (inflammatory bowel disease, colectomy/ colostomy/diverticular disease).
- Allergy/intolerance/contraindication to any medication or component included in the ERAS pathway protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery Pathway (ERP) for SpineThe 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. | Other | Enhanced Recovery Pathway for Spine |
Primary outcome
Patient Score on QoR40 Inventory.
Time frame: Postoperative Day 3
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).
10 secondary outcomes
Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals.
Time frame: Postoperative Day 5
Pain Control: Opioid Consumption.
Time frame: 48 hours after surgery
Pain Control: NRS Rating Scales of Pain After Physical Therapy on Postoperative Day 1
Time frame: Postoperative Day 1
Time to Post-operative Oral Intake.
Time frame: Postoperative Day 1
Number of Participants With Post-operative Nausea, Vomiting and Ileus
Time frame: Postoperative Day 5
Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml).
Time frame: Postoperative Days 0, 1, and 3
Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl).
Time frame: Postoperative Days 0, 1, and 3
Levels of Plasma Markers of Surgical Stress: CRP (mg/dL).
Time frame: Postoperative Days 0, 1, and 3
Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml).
Time frame: Postoperative Days 0, 1, and 3
Number of Participants With Presence of Delirium/Confusion, Infection, DVT/PE
Time frame: Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Soffin, MD, PhD principal investigator
Hospital for Special Surgery, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery Pathway (ERP) for Spine in people with Enhanced Recovery After Surgery and Spine Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Score on QoR40 Inventory. (time frame: Postoperative Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.