Clinical trial
A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications
Name
1586560
Description
This study aims to determine the impact and effect of enhanced recovery after surgery (ERAS) principles in the recovery and rehabilitation of patients following elective orthopaedic spine surgery with a specific emphasis on oral versus intravenous preoperative medication administration and the resultant cost differences.
Trial arms
Trial start
2020-11-18
Estimated PCD
2024-06-15
Trial end
2024-06-15
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Intravenous Infusion group
The intravenous infusion group will receive two medications via the intravenous infusion route. These medications are Ofirmev ( acetaminophen ) 1,000mg and tranexamic acid 2,000 mg , an antifibrinolytic drug. In addition to these drugs, study subjects will receive Celecoxib 200mg by mouth and Gabapentin 600 mg by mouth prior to operation.
Arms:
Group B: Intravenous agents
All oral administration group
Subjects in the oral administration group will receive the following pre-emptive analgesic drugs, acetaminophen 1,000mg, Celecoxib 200mg and gabapentin 600mg via the oral route prior to operation. In addition they will receive the antifibrinolytic drug, tranexamic acid 2,000mg via an oral route as well prior to operation.
Arms:
Group A: All oral pre-operative analgesics
Size
150
Primary endpoint
Operative blood loss (ml)
From incision start to wound closed. 0-6 hours after operation start.
Postoperative pain scores (VAS) Visual analog scale.
The investigators will measure change between baseline/pre-surgical VAS score to immediate post surgical VAS, and at 4 hour intervals until hospital discharge. 0-48 hours
Immediate postoperative opiate analgesic requirement
From post anesthesia care unit admission until hospital discharge. As the investigators are measuring the 24 hour Morphine equivalent dosing from anesthesia emergence until hospital discharge. ( 0-48 hours after operation)
Time from post-anesthesia care unit (PACU) admission to discharge
PACU admission to PACU discharge (range 0-6 hours)
blood transfusion requirement
At any time point during hospitalization. ( 0-48 hours after operation)
Length of hospital stay
From day of operation (day zero) through hospital discharge.Expected range 1-3 days)
Eligibility criteria
Inclusion Criteria:
· Surgery scheduled for lumbar decompression and fusions 1 to 3 levels
Exclusion Criteria:
* Cervical, thoracic, or lumbar trauma
* Oncologic procedures
* Patient's with comorbidities preventing early postoperative mobilization
* Patients with contraindications to tranexamic acid (TXA) administration including but not limited to patients with a history of thromboembolic or ischemic events (PE, DVT, CVA, MI). Additional contraindications are decided by treating orthopaedic surgeon
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators are comparing the efficacy of commonly administered pre-emptive analgesic medications administered in a randomized fashion in parallel. In one group all medications will be administered by mouth and in one group two of the medications will be administered via the intravenous route.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-06-18
1 organization
2 products
1 indication
Organization
University of California, DavisProduct
Intravenous InfusionIndication
Lumbar Surgery