Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion: A Randomized Controlled Study

In light of the current opioid epidemic, there is an urgent need to address chronic opioid use prior to surgery before it is exacerbated by postoperative surgical pain. Our central hypothesis is that patients who taper their opioid use prior to surgery will have reduced postoperative opioid and pain medication usage, less postoperative pain, and improved patient reported outcomes relative to patients that do not taper prior to surgery. Our specific aims include: 1. Determine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative opioid and pain medication use. 2. Examine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative pain. 3. Determine whether reducing patients' preoperative opioid usage through a structured tapering regimen improves patient reported outcomes.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use; Spine Fusion
• Intervention / Treatment: Behavioral: Spinal Fusion Preoperative Opioid Taper; Other: Non-taper Control

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akaila Cabell, MD'; Phone Number: 2629301528; Email: acabell4@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Hospital and Clinics
      • Contact: Susmita Chatterjee; Phone Number: 650-497-9271; Email: susmitac@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Indicated for lumbar, lumbosacral, or thoracolumbar spinal fusion surgery in the departments of Orthopedic Surgery and Neurosurgery
• Daily opioid use for at least 4 weeks prior to the preoperative planning appointment

Exclusion Criteria:

• Suboxone (buprenorphine) use
• Unable to complete patient reported outcome measures (PROMs)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid Taper Group; Patients randomized to the taper group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive a scheduled tapering protocol, with a goal of 10-15% reduction in their weekly opioid use, along with weekly phone calls from a study coordinator assessing their ability to taper and pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.	Behavioral: Spinal Fusion Preoperative Opioid Taper; Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.
Active Comparator: Control Group; Patients randomized to the control group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive no recommendation or guidance in their preoperative opioid pain medication use, but will received weekly phone calls from a study coordinator assessing their preoperative pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.	Other: Non-taper Control; Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Postoperative Opioid Pain Medication Dose	Weekly average opioid medication use in morphine equivalent dosage (MED)	Weekly, month 3, month 6
Change in Numeric Pain Scale Score	Generic measure of average back pain, scale 0-10 with 0 being no pain and 10 being the most pain experienced.	Weekly, month 3, month 6
Change from baseline Patient Reported Outcome Measures (PROMs)	PROMIS computer adaptive testing: global health, physical function, pain interference, pain behavior, depression, anxiety, fatigue, sleep disturbance, and satisfaction with social roles and activities.	Weekly, month 3, month 6

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Crisostomo RA, Schmidt JE, Hooten WM, Kerkvliet JL, Townsend CO, Bruce BK. Withdrawal of analgesic medication for chronic low-back pain patients: improvement in outcomes of multidisciplinary rehabilitation regardless of surgical history. Am J Phys Med Rehabil. 2008 Jul;87(7):527-36. doi: 10.1097/PHM.0b013e31817c124f.
• Chu LF, Clark DJ, Angst MS. Opioid tolerance and hyperalgesia in chronic pain patients after one month of oral morphine therapy: a preliminary prospective study. J Pain. 2006 Jan;7(1):43-8. doi: 10.1016/j.jpain.2005.08.001.
• Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
• Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.
• Fishbain DA, Rosomoff HL, Cutler R. Opiate detoxification protocols. A clinical manual. Ann Clin Psychiatry. 1993 Mar;5(1):53-65. doi: 10.3109/10401239309148924.
• Baron MJ, McDonald PW. Significant pain reduction in chronic pain patients after detoxification from high-dose opioids. J Opioid Manag. 2006 Sep-Oct;2(5):277-82. doi: 10.5055/jom.2006.0041.
• Berna C, Kulich RJ, Rathmell JP. Tapering Long-term Opioid Therapy in Chronic Noncancer Pain: Evidence and Recommendations for Everyday Practice. Mayo Clin Proc. 2015 Jun;90(6):828-42. doi: 10.1016/j.mayocp.2015.04.003.
• Chu LF, Angst MS, Clark D. Opioid-induced hyperalgesia in humans: molecular mechanisms and clinical considerations. Clin J Pain. 2008 Jul-Aug;24(6):479-96. doi: 10.1097/AJP.0b013e31816b2f43.
• Farrell M. Opiate withdrawal. Addiction. 1994 Nov;89(11):1471-5. doi: 10.1111/j.1360-0443.1994.tb03745.x.
• Heiwe S, Lonnquist I, Kallmen H. Potential risk factors associated with risk for drop-out and relapse during and following withdrawal of opioid prescription medication. Eur J Pain. 2011 Oct;15(9):966-70. doi: 10.1016/j.ejpain.2011.03.006. Epub 2011 May 4.
• Mirza SK, Deyo RA, Heagerty PJ, Konodi MA, Lee LA, Turner JA, Goodkin R. Development of an index to characterize the "invasiveness" of spine surgery: validation by comparison to blood loss and operative time. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2651-61; discussion 2662. doi: 10.1097/BRS.0b013e31818dad07.
• Nguyen LC, Sing DC, Bozic KJ. Preoperative Reduction of Opioid Use Before Total Joint Arthroplasty. J Arthroplasty. 2016 Sep;31(9 Suppl):282-7. doi: 10.1016/j.arth.2016.01.068. Epub 2016 Mar 17.
• Nilsen HK, Stiles TC, Landro NI, Fors EA, Kaasa S, Borchgrevink PC. Patients with problematic opioid use can be weaned from codeine without pain escalation. Acta Anaesthesiol Scand. 2010 May;54(5):571-9. doi: 10.1111/j.1399-6576.2009.02164.x. Epub 2009 Nov 16.
• Ralphs JA, de C Williams AC, Richardson PH, Pither CE, Nicholas MK. Opiate reduction in chronic pain patients: a comparison of patient-controlled reduction and staff controlled cocktail methods. Pain. 1994 Mar;56(3):279-288. doi: 10.1016/0304-3959(94)90166-X.
• Tennant FS Jr, Rawson RA. Outpatient treatment of prescription opioid dependence: comparison of two methods. Arch Intern Med. 1982 Oct;142(10):1845-7.
• Townsend CO, Kerkvliet JL, Bruce BK, Rome JD, Hooten MW, Luedtke CA, Hodgson JE. A longitudinal study of the efficacy of a comprehensive pain rehabilitation program with opioid withdrawal: comparison of treatment outcomes based on opioid use status at admission. Pain. 2008 Nov 15;140(1):177-189. doi: 10.1016/j.pain.2008.08.005. Epub 2008 Sep 19.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 47240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No