Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095624
• Other study ID #: 47240
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: Akaila Cabell, MD'
• Phone: 2629301528
• Email: acabell4[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid Use
• Spine Fusion

Intervention

Behavioral:
• Spinal Fusion Preoperative Opioid Taper
Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.

Other:
• Non-taper Control
Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Farrell M. Opiate withdrawal. Addiction. 1994 Nov;89(11):1471-5. Review. — View Citation

Fishbain DA, Rosomoff HL, Cutler R. Opiate detoxification protocols. A clinical manual. Ann Clin Psychiatry. 1993 Mar;5(1):53-65. Review. — View Citation

Heiwe S, Lönnquist I, Källmén 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. — View Citation

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. — View Citation

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. — View Citation

Nilsen HK, Stiles TC, Landrø 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. — View Citation

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. — View Citation

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. — View Citation

Tennant FS Jr, Rawson RA. Outpatient treatment of prescription opioid dependence: comparison of two methods. Arch Intern Med. 1982 Oct;142(10):1845-7. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Postoperative Opioid Pain Medication Dose	Weekly average opioid medication use in morphine equivalent dosage (MED)	Weekly, month 3, month 6
Primary	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
Primary	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

External Links

•   Centers for Disease Control and Prevention, National Center for Injury Prevention and Control and Division of Unintentional Injury Prevention (no date) Analyzing Prescription Data and Morphine Milligram Equivalents (MME).