Lumbar SurgeryPhase 2/3ERASNCT04562610
Enhanced Recovery After Surgery in Orthopaedic Spine Surgery
A Phase 2/3 study testing Intravenous Infusion group and All oral administration group in people with Lumbar Surgery, run by University of California, Davis at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Lumbar Surgery
- What is being tested?
- Intravenous Infusion group and All oral administration group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 9 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery scheduled for lumbar decompression and fusions 1 to 3 levels
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications
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.
Read the detailed description
In orthopaedic surgery, ERAS programs have profoundly impacted outcomes in hip and knee replacement surgery.4 Large, prospective studies have demonstrated a reduction in mortality rate, median length of stay, and blood transfusion rates with no change in re-admission rates.5,6 However, there is a paucity of data evaluating the application of ERAS principles in other orthopaedic subspecialties, especially elective spine surgery. With over 35,000 cervical spine procedures performed in 2011, almost 200,000 elective lumbar fusion surgeries performed in 2015, and 83.7 million people estimated to be ≥ 65 years old in 2050, the demand for elective spine surgery is high and will continue to grow placing a significant economic burden on the health care system.This increasing demand in conjunction with prolonged hospital stays, extensive postoperative pain regimens, and the advent of minimally invasive procedures provides a compelling argument for the suitability of ERAS protocols in elective spine surgery.
While distinct components of the ERAS pathway have been investigated in spine surgery including preoperative education, multimodal pain management, surgical approach, nutrition, and physical therapy, few studies have investigated the collective application of these interventions. Furthermore, these studies have been retrospective in nature, limiting their generalizability.The goal of this study is to perform a prospective, randomized trial to evaluate the efficacy and cost-effectiveness of oral versus intravenous medications preoperatively. The investigators also plan to evaluate the effect of the implementation of the standard of care ERAS principles on the outcome of patients undergoing elective spine surgery.
- Conditions
- Lumbar Surgery
- Being tested
- Intravenous Infusion group, All oral administration group
- Keywords
- lumbar decompression and fusions 1 to 3 levels, lumbar decompression and fusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Infusion groupDrug
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.
All oral administration groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: All oral pre-operative analgesics | Active comparator | Group A patients will be administered the following medications in the preoperative holding area:
* Acetaminophen 1,000 mg by mouth prior to operation
* Celecoxib 200mg by mouth prior to operation
* Tranexamic acid 2 grams by mouth prior to operation
* Gabapentin 600mg by mouth prior to operation Receives: Drug: All oral administration group |
| Group B: Intravenous agents | Active comparator | Group B patients will receive:
* Acetaminophen (Ofirmev) 1,000mg intravenous prior to operation
* Celecoxib 200mg by mouth prior to operation
* Tranexamic acid 2grams intravenous at start of operation
* Gabapentin 600 mg by mouth prior to operation Receives: Drug: Intravenous Infusion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative blood loss (ml)
Actual or estimated blood loss during operation. This is typically included in the surgeons operative note.
Measured: From incision start to wound closed. 0-6 hours after operation start.
Postoperative pain scores (VAS) Visual analog scale.
Visual analog pain score from 1-10 points reported by patient with 10 severe pain and 0 being no pain. The investigators are comparing the efficacy of two different analgesia regimens, this is a critical primary outcome measure.
Measured: 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
Immediate post procedure Opiate analgesic requirement measured in Morphine equivalents (mg)
Measured: 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
This is the time from anesthesia emergence to initiation of meaningful activity. and recovery measured from anesthetic (in hours) with a range of 1-12 hours.
Measured: PACU admission to PACU discharge (range 0-6 hours)
blood transfusion requirement
Amount of blood transfused expressed in milliliters (ml). As this may range from binary ( yes or no ) and could also be recorded in volume milliliters; the owill record and report both.
Measured: At any time point during hospitalization. ( 0-48 hours after operation)
Length of hospital stay
Length of hospital stay (LOS) in days with a range from 1-6 days.
Measured: From day of operation (day zero) through hospital discharge.Expected range 1-3 days)
Secondary outcomes (5)
Overall cost of hospitalization.
Total cost of hospitalization including hospital stay, pharmacy charges, and other professional fees.
Measured: Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.
Post operative complications
This outcome will be binary (yes/no). The investigators will record the occurrence of any operative or postoperative complications from hospital admission to hospital discharge. If no complications occur these will be recorded as zero; should complications occur during hospitalization, these complication will be recorded (readmission rate, infection, wound dehiscence, return to OR, deep vein thrombosis/pulmonary embolism (DVT/PE). Intra-operative complications, postoperative complications, including but not limited to respiratory events, GI complications including ileus, postoperative nausea and vomiting, ground level falls, orthostatic hypotensive events or any complication associated with early mobilization. The number of complications will be listed in addition to the individual complication type.
Measured: From initiation of operation to hospital discharge (Day1-3)
Oswestry Disability Index (ODI)
10 question survey instrument with domains which include pain, physical, and social function. The range of scores is from 0-100 with 0 being no disability and 100 representing bedbound patients with no capacity to function in any domain.
Measured: The investigators will measure change between baseline (ODI) and at surgical visits and 12 months after operation.
Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)
NIH computer adapted technology patient reported outcomes measures of pain interference, physical function, depression, anxiety, and upper extremity function.
Measured: The investigators will measure change between PROMIS CAT scores between between baseline and 12 months after operation.
University of California, Davis Short Form 20 (UCD SF-20)
Patient reported outcome instrument with 20 questions and score between range 0- 100 points. Domains surveyed include self perception of health, bodily pain, social function, physical function and role emotional health.
Measured: The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start18 Nov 2020
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lumbar SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolando F Roberto, MD, Principal investigator, Univeristy of California Davis Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562610
- Sponsor's protocol ID
- 1586560
- Acronym
- ERAS
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2020
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PubMed 9175983Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
PubMed 25501695Wainwright TW, Immins T, Middleton RG. Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):91-102. doi: 10.1016/j.bpa.2015.11.001. Epub 2015 Nov 23.
PubMed 27036606Starks I, Wainwright TW, Lewis J, Lloyd J, Middleton RG. Older patients have the most to gain from orthopaedic enhanced recovery programmes. Age Ageing. 2014 Sep;43(5):642-8. doi: 10.1093/ageing/afu014. Epub 2014 Mar 13.
PubMed 24627354Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.
PubMed 26209853Marquez-Lara A, Nandyala SV, Fineberg SJ, Singh K. Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011. Spine (Phila Pa 1976). 2014 Mar 15;39(6):476-81. doi: 10.1097/BRS.0000000000000165.
PubMed 24365907Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
PubMed 30074971Ortman, Jennifer M, Velkoff, Victoria A, Hogan H. An Aging Nation: The Older Population in the United States. Washington DC; 2014.
Smith J, Probst S, Calandra C, Davis R, Sugimoto K, Nie L, Gan TJ, Bennett-Guerrero E. Enhanced recovery after surgery (ERAS) program for lumbar spine fusion. Perioper Med (Lond). 2019 May 28;8:4. doi: 10.1186/s13741-019-0114-2. eCollection 2019.
PubMed 31149331Corniola MV, Debono B, Joswig H, Lemee JM, Tessitore E. Enhanced recovery after spine surgery: review of the literature. Neurosurg Focus. 2019 Apr 1;46(4):E2. doi: 10.3171/2019.1.FOCUS18657.
PubMed 31018257Angus M, Jackson K, Smurthwaite G, Carrasco R, Mohammad S, Verma R, Siddique I. The implementation of enhanced recovery after surgery (ERAS) in complex spinal surgery. J Spine Surg. 2019 Mar;5(1):116-123. doi: 10.21037/jss.2019.01.07.
PubMed 31032446Elsarrag M, Soldozy S, Patel P, Norat P, Sokolowski JD, Park MS, Tvrdik P, Kalani MYS. Enhanced recovery after spine surgery: a systematic review. Neurosurg Focus. 2019 Apr 1;46(4):E3. doi: 10.3171/2019.1.FOCUS18700.
PubMed 30933920de Castro SM, van den Esschert JW, van Heek NT, Dalhuisen S, Koelemay MJ, Busch OR, Gouma DJ. A systematic review of the efficacy of gum chewing for the amelioration of postoperative ileus. Dig Surg. 2008;25(1):39-45. doi: 10.1159/000117822. Epub 2008 Feb 21.
PubMed 18292660Ali ZS, Ma TS, Ozturk AK, Malhotra NR, Schuster JM, Marcotte PJ, Grady MS, Welch WC. Pre-optimization of spinal surgery patients: Development of a neurosurgical enhanced recovery after surgery (ERAS) protocol. Clin Neurol Neurosurg. 2018 Jan;164:142-153. doi: 10.1016/j.clineuro.2017.12.003. Epub 2017 Dec 8.
PubMed 29232645
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Enhanced Recovery After Surgery in Orthopaedic Spine Surgery: Administration of Preoperative Oral Versus Intravenous Medications
- ClinicalTrials.gov ID
- NCT04562610
- Acronym / sponsor ID
- ERAS / 1586560
- Conditions
- Lumbar Surgery
- Keywords
- lumbar decompression and fusions 1 to 3 levels, lumbar decompression and fusions
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In orthopaedic surgery, ERAS programs have profoundly impacted outcomes in hip and knee replacement surgery.4 Large, prospective studies have demonstrated a reduction in mortality rate, median length of stay, and blood transfusion rates with no change in re-admission rates.5,6 However, there is a paucity of data evaluating the application of ERAS principles in other orthopaedic subspecialties, especially elective spine surgery. With over 35,000 cervical spine procedures performed in 2011, almost 200,000 elective lumbar fusion surgeries performed in 2015, and 83.7 million people estimated to be ≥ 65 years old in 2050, the demand for elective spine surgery is high and will continue to grow placing a significant economic burden on the health care system.This increasing demand in conjunction with prolonged hospital stays, extensive postoperative pain regimens, and the advent of minimally invasive procedures provides a compelling argument for the suitability of ERAS protocols in elective spine surgery.
While distinct components of the ERAS pathway have been investigated in spine surgery including preoperative education, multimodal pain management, surgical approach, nutrition, and physical therapy, few studies have investigated the collective application of these interventions. Furthermore, these studies have been retrospective in nature, limiting their generalizability.The goal of this study is to perform a prospective, randomized trial to evaluate the efficacy and cost-effectiveness of oral versus intravenous medications preoperatively. The investigators also plan to evaluate the effect of the implementation of the standard of care ERAS principles on the outcome of patients undergoing elective spine surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: All oral pre-operative analgesics | Active comparator | Drug: All oral administration groupGroup A patients will be administered the following medications in the preoperative holding area: * Acetaminophen 1,000 mg by mouth prior to operation * Celecoxib 200mg by mouth prior to operation * Tranexamic acid 2 grams by mouth prior to operation * Gabapentin 600mg by mouth prior to operation |
| Group B: Intravenous agents | Active comparator | Drug: Intravenous Infusion groupGroup B patients will receive: * Acetaminophen (Ofirmev) 1,000mg intravenous prior to operation * Celecoxib 200mg by mouth prior to operation * Tranexamic acid 2grams intravenous at start of operation * Gabapentin 600 mg by mouth prior to operation |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgery scheduled for lumbar decompression and fusions 1 to 3 levels
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Intravenous Infusion groupThe 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. | Drug | Group B: Intravenous agents |
| All oral administration groupSubjects 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. | Drug | Group A: All oral pre-operative analgesics |
Primary outcome
Operative blood loss (ml)
Time frame: From incision start to wound closed. 0-6 hours after operation start.
Actual or estimated blood loss during operation. This is typically included in the surgeons operative note.
Postoperative pain scores (VAS) Visual analog scale.
Time frame: 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
Visual analog pain score from 1-10 points reported by patient with 10 severe pain and 0 being no pain. The investigators are comparing the efficacy of two different analgesia regimens, this is a critical primary outcome measure.
Immediate postoperative opiate analgesic requirement
Time frame: 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)
Immediate post procedure Opiate analgesic requirement measured in Morphine equivalents (mg)
Time from post-anesthesia care unit (PACU) admission to discharge
Time frame: PACU admission to PACU discharge (range 0-6 hours)
This is the time from anesthesia emergence to initiation of meaningful activity. and recovery measured from anesthetic (in hours) with a range of 1-12 hours.
blood transfusion requirement
Time frame: At any time point during hospitalization. ( 0-48 hours after operation)
Amount of blood transfused expressed in milliliters (ml). As this may range from binary ( yes or no ) and could also be recorded in volume milliliters; the owill record and report both.
Length of hospital stay
Time frame: From day of operation (day zero) through hospital discharge.Expected range 1-3 days)
Length of hospital stay (LOS) in days with a range from 1-6 days.
5 secondary outcomes
Overall cost of hospitalization.
Time frame: Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.
Post operative complications
Time frame: From initiation of operation to hospital discharge (Day1-3)
Oswestry Disability Index (ODI)
Time frame: The investigators will measure change between baseline (ODI) and at surgical visits and 12 months after operation.
Patient Reported Outcome Measurement Information System, Computer Adaptive Tests (PROMIS CAT)
Time frame: The investigators will measure change between PROMIS CAT scores between between baseline and 12 months after operation.
University of California, Davis Short Form 20 (UCD SF-20)
Time frame: The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 9175983Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
- Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background: PubMed 25501695Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.
- Background: PubMed 27036606Wainwright TW, Immins T, Middleton RG. Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):91-102. doi: 10.1016/j.bpa.2015.11.001. Epub 2015 Nov 23.
- Background: PubMed 24627354Starks I, Wainwright TW, Lewis J, Lloyd J, Middleton RG. Older patients have the most to gain from orthopaedic enhanced recovery programmes. Age Ageing. 2014 Sep;43(5):642-8. doi: 10.1093/ageing/afu014. Epub 2014 Mar 13.
- Background: PubMed 26209853Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.
- Background: PubMed 24365907Marquez-Lara A, Nandyala SV, Fineberg SJ, Singh K. Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011. Spine (Phila Pa 1976). 2014 Mar 15;39(6):476-81. doi: 10.1097/BRS.0000000000000165.
- Background: PubMed 30074971Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- BackgroundOrtman, Jennifer M, Velkoff, Victoria A, Hogan H. An Aging Nation: The Older Population in the United States. Washington DC; 2014.
- Background: PubMed 31149331Smith J, Probst S, Calandra C, Davis R, Sugimoto K, Nie L, Gan TJ, Bennett-Guerrero E. Enhanced recovery after surgery (ERAS) program for lumbar spine fusion. Perioper Med (Lond). 2019 May 28;8:4. doi: 10.1186/s13741-019-0114-2. eCollection 2019.
- Background: PubMed 31018257Corniola MV, Debono B, Joswig H, Lemee JM, Tessitore E. Enhanced recovery after spine surgery: review of the literature. Neurosurg Focus. 2019 Apr 1;46(4):E2. doi: 10.3171/2019.1.FOCUS18657.
- Background: PubMed 31032446Angus M, Jackson K, Smurthwaite G, Carrasco R, Mohammad S, Verma R, Siddique I. The implementation of enhanced recovery after surgery (ERAS) in complex spinal surgery. J Spine Surg. 2019 Mar;5(1):116-123. doi: 10.21037/jss.2019.01.07.
- Learn more or sign up for the study here!Link provided by the sponsor.
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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.
Rolando F Roberto, MD principal investigator
Univeristy of California Davis Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous Infusion group and All oral administration group in people with Lumbar Surgery, run by University of California, Davis 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 4 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 21 Aug 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operative blood loss (ml) (time frame: From incision start to wound closed. 0-6 hours after operation start.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562610, which also lists 16 linked publications.
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 21 Aug 2025.