Study of Opioid Use After Lumbar and Cervical Spine Surgery

Low Back Pain Clinical Trial

— SOULCS  

Official title:

The Effect of a Brief Pre-operative Pain Medication Educational Video on Post-operative Prescription Opioid Medication Use in Patients Undergoing Spine Surgery. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674711
• Other study ID #: C.2015.048d
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2022
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.

Description:

After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon.

Education Group:

The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage.

All Subjects:

All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon.

All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted, and then again at 6 months to ask history of prescription opioid utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2018
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or neurosurgeon specifically for a lumbar surgery.

2. Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)

3. Between the age of 18 - 65 years

4. Read and speak English well enough to understand the education, provide informed consent and follow study instructions

Exclusion Criteria:

a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Neck Pain
• Opiate Addiction
• Opioid-Related Disorders

Intervention

Behavioral:
• Educational Video
The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Baylor University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009 Feb;10(2):147-59. doi: 10.1016/j.jpain.2008.10.007. — View Citation

Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004959. doi: 10.1002/14651858.CD004959.pub3. — View Citation

Devin CJ, Lee DS, Armaghani SJ, Bible J, Shau DN, Martin PR, Ehrenfeld JM. Approach to pain management in chronic opioid users undergoing orthopaedic surgery. J Am Acad Orthop Surg. 2014 Oct;22(10):614-22. doi: 10.5435/JAAOS-22-10-614. — View Citation

Lee D, Armaghani S, Archer KR, Bible J, Shau D, Kay H, Zhang C, McGirt MJ, Devin C. Preoperative Opioid Use as a Predictor of Adverse Postoperative Self-Reported Outcomes in Patients Undergoing Spine Surgery. J Bone Joint Surg Am. 2014 Jun 4;96(11):e89. doi: 10.2106/JBJS.M.00865. Epub 2014 Jun 4. — View Citation

Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJ, Fellows B, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm S 2nd, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Silverman SM, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician. 2012 Jul;15(3 Suppl):S67-116. — View Citation

Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007 Jan 16;146(2):116-27. doi: 10.7326/0003-4819-146-2-200701160-00006. — View Citation

Rhon DI, Greenlee TA, Mayhew R, Boyer C, Laugesen M, Roth J, Dowd TC, Gill NW. Engaging Education About Risks of Opioid Use With Patients Before Elective Surgery of the Lower Extremity Did Not Reduce Postoperative Opioid Utilization: A Randomized Controll — View Citation

Trescot AM, Boswell MV, Atluri SL, Hansen HC, Deer TR, Abdi S, Jasper JF, Singh V, Jordan AE, Johnson BW, Cicala RS, Dunbar EE, Helm S 2nd, Varley KG, Suchdev PK, Swicegood JR, Calodney AK, Ogoke BA, Minore WS, Manchikanti L. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006 Jan;9(1):1-39. — View Citation

Walid MS, Hyer L, Ajjan M, Barth AC, Robinson JS Jr. Prevalence of opioid dependence in spine surgery patients and correlation with length of stay. J Opioid Manag. 2007 May-Jun;3(3):127-8, 130-2. doi: 10.5055/jom.2007.0050. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Opioid Medication Prescriptions	Number of prescriptions within 12 months after surgery	12 months
Secondary	Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI)	The ODI and NDI are 10-item scales with higher numbers indicating greater disability. Each item has 6 possible questions (0-5), which are then summed and multiplied to provide a % score out of 100%. The ODI focused on low back pain and the NDI on neck pain. As values are on the same scale, they were entered as one outcome since we included both neck and low back pain patients. Patients undergoing cervical spine surgery filled out the NDI (Neck Disability Index) and patients undergoing lumbar spine surgery filled out the ODI (Oswestry Disability Index)	6 months
Secondary	Numeric Pain Rating Scale (NPRS)	A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess pain intensity.	6 months