Enhanced Recovery After Surgery Clinical Trial
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
NCT number | NCT02949518 |
Other study ID # | 2016-617 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 28, 2016 |
Est. completion date | May 2020 |
Verified date | July 2020 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Any patient presenting for 1 or 2 level posterior lumbar fusion. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Postoperative Day 3 | |
Secondary | Length of Stay and Time From Surgery to Meeting Discharge and Physical Therapy Goals. | Measured in days after surgery (in half-day increments). | Postoperative Day 5 | |
Secondary | Pain Control: Opioid Consumption. | Measured in morphine equivalents daily. | 48 hours after surgery | |
Secondary | 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 | Postoperative Day 1 | |
Secondary | Time to Post-operative Oral Intake. | Measured in hours | Postoperative Day 1 | |
Secondary | 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 | Postoperative Day 5 | |
Secondary | Levels of Plasma Markers of Surgical Stress: IL-6 (pg/ml). | Postoperative Days 0, 1, and 3 | ||
Secondary | Levels of Plasma Markers of Surgical Stress: Cortisol (mcg/dl). | Postoperative Days 0, 1, and 3 | ||
Secondary | Levels of Plasma Markers of Surgical Stress: CRP (mg/dL). | Postoperative Days 0, 1, and 3 | ||
Secondary | Levels of Plasma Markers of Surgical Stress: Insulin Resistance (µIU/ml). | Postoperative Days 0, 1, and 3 | ||
Secondary | 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. | Entire Hospital Admission, but Measure at Discharge (Up to Postoperative Day 5) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04963751 -
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
|
N/A | |
Recruiting |
NCT04072419 -
Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period
|
||
Recruiting |
NCT05564819 -
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants
|
Phase 1 | |
Recruiting |
NCT05613439 -
The Fast-track Centre for Hip and Knee Replacement Database
|
||
Completed |
NCT04543214 -
Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery
|
||
Not yet recruiting |
NCT05576766 -
Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
|
N/A | |
Recruiting |
NCT05081804 -
The Effect of Enhanced Recovery After Surgery (ERAS) for Cesarean Section on Neonatal Blood Glucose
|
N/A | |
Completed |
NCT04538235 -
Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.
|
||
Not yet recruiting |
NCT05914090 -
The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult
|
N/A | |
Recruiting |
NCT05541640 -
Intraoperative Lidocaine Infusion and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery
|
N/A | |
Not yet recruiting |
NCT05511194 -
Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children
|
N/A | |
Recruiting |
NCT05528484 -
Self-reported Outcomes of Patients in ERAS Nursing
|
N/A | |
Recruiting |
NCT04596800 -
Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial
|
Phase 3 | |
Completed |
NCT04648644 -
Application of ERAS Protocol in Emergency Surgery
|
||
Active, not recruiting |
NCT06457100 -
Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery
|
Phase 1/Phase 2 | |
Recruiting |
NCT06137976 -
Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy
|
N/A | |
Completed |
NCT06118593 -
Why in Hospital After Wedge Resection
|
||
Active, not recruiting |
NCT06369194 -
POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
|
||
Recruiting |
NCT04576533 -
Patients Undergoing Laparoscopic Colorectal Surgery Walk Out From Operating Room After Surgery ( WOFOR-C1 )
|
N/A | |
Not yet recruiting |
NCT04397627 -
ERAS Program Items Adherence, PROMs and RIOT After Colorectal Surgery
|