Enhanced Recovery After Surgery in Orthopaedic Spine Surgery

NCT04562610 | Completed Phase 2 FDA Drug

• 1 other identifier: 1586560
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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 differences.

Conditions

Lumbar Surgery

Keywords

lumbar decompression and fusions 1 to 3 levels; lumbar decompression and fusions

Outcome Measures

Primary Outcomes (6)

• Operative blood loss (ml)

  Actual or estimated blood loss during operation. This is typically included in the surgeons operative note.

  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.

  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)

  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.

  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.

  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.

  From day of operation (day zero) through hospital discharge.Expected range 1-3 days)

Secondary Outcomes (5)

• Overall cost of hospitalization.

  Admission to outpatient surgery until discharge from the hospital, range expected 6-72 hours.

• Post operative complications

  From initiation of operation to hospital discharge (Day1-3)

• Oswestry Disability Index (ODI)

  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)

  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)

  The investigators will measure change between baseline pre-op SF-20 scores and 12 months after operation

Study Arms (2)

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

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

Drug: Intravenous Infusion group

Interventions

Intravenous Infusion group DRUG

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.

Group B: Intravenous agents

All oral administration group DRUG

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.

Group A: All oral pre-operative analgesics

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · Surgery scheduled for lumbar decompression and fusions 1 to 3 levels

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (16)

• 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.

  PMID: 9175983 BACKGROUND

• Ljungqvist 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.

  PMID: 28097305 BACKGROUND

• Carli 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.

  PMID: 25501695 BACKGROUND

• Wainwright 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.

  PMID: 27036606 BACKGROUND

• Starks 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.

  PMID: 24627354 BACKGROUND

• Aasvang 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.

  PMID: 26209853 BACKGROUND

• Marquez-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.

  PMID: 24365907 BACKGROUND

• Martin 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.

  PMID: 30074971 BACKGROUND

• Ortman, Jennifer M, Velkoff, Victoria A, Hogan H. An Aging Nation: The Older Population in the United States. Washington DC; 2014.

  BACKGROUND

• 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.

  PMID: 31149331 BACKGROUND

• Corniola 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.

  PMID: 31018257 BACKGROUND

• Angus 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.

  PMID: 31032446 BACKGROUND

• Elsarrag 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.

  PMID: 30933920 BACKGROUND

• de 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.

  PMID: 18292660 BACKGROUND

• Ali 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.

  PMID: 29232645 BACKGROUND

• Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.

  PMID: 24417824 BACKGROUND

Related Links

• Learn more or sign up for the study here!

Study Officials

• Rolando F Roberto, MD

  Univeristy of California Davis Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: September 24, 2020
• Study Start: November 18, 2020
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)