Opioid UseNCT04095624

Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

A study testing Spinal Fusion Preoperative Opioid Taper in people with Opioid Use and Spine Fusion, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Use, Spine Fusion
What is being tested?: Spinal Fusion Preoperative Opioid Taper
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 9 Sep 2019to 1 Jul 2023
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Hospital and Clinics
Redwood City, California, 94063

Other trials in United States

About this study

Official title: 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.

Conditions: Opioid Use, Spine Fusion
Being tested: Spinal Fusion Preoperative Opioid Taper, Non-taper Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal Fusion Preoperative Opioid TaperBehavioural
Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.
Non-taper ControlOther
Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.

Study groups in NCT04095624
Study group	Role	What they receive
Opioid Taper Group	Experimental	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. Receives: Behavioral: Spinal Fusion Preoperative Opioid Taper
Control Group	Active comparator	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. Receives: Other: Non-taper Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Postoperative Opioid Pain Medication Dose
Weekly average opioid medication use in morphine equivalent dosage (MED)
Measured: 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.
Measured: 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.
Measured: Weekly, month 3, month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 20191 Jul 2023

First posted19 Sep 2019
Study start9 Sep 2019
Primary completion1 Jul 2023
Study completion1 Jul 2023

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 Opioid UseStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04095624
Sponsor's protocol ID: 47240
Status last verified: Jul 2022
First submitted: 3 Jun 2019
Last updated: 11 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 17319259
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.
PubMed 18443635
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.
PubMed 26046416
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.
PubMed 18574358
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.
PubMed 16414554
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.
PubMed 18574345
Farrell M. Opiate withdrawal. Addiction. 1994 Nov;89(11):1471-5. doi: 10.1111/j.1360-0443.1994.tb03745.x.
PubMed 7841858
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.
PubMed 8394176
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.
PubMed 21546290
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.
PubMed 18981957
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.
PubMed 27105557
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.
PubMed 19919582
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.
PubMed 18165753
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.
PubMed 8022621
Tennant FS Jr, Rawson RA. Outpatient treatment of prescription opioid dependence: comparison of two methods. Arch Intern Med. 1982 Oct;142(10):1845-7.
PubMed 6181749

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT04095624
Acronym / sponsor ID: 47240
Conditions: Opioid Use, Spine Fusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 9 Sep 2019 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 1 Jul 2023 (actual)
First posted: 19 Sep 2019 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Opioid Taper Group	Experimental	Behavioral: Spinal Fusion Preoperative Opioid TaperPatients 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.
Control Group	Active comparator	Other: Non-taper ControlPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

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
Spinal Fusion Preoperative Opioid TaperGuided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.	Behavioural	Opioid Taper Group
Non-taper ControlWeekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.	Other	Control Group

Primary outcome

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

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 11 Apr 2025.
Background: PubMed 17319259Baron 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.
Background: PubMed 18443635Benyamin 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.
Background: PubMed 26046416Berna 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.
Background: PubMed 18574358Chu 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.
Background: PubMed 16414554Chu 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.
Background: PubMed 18574345Crisostomo 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.
Background: PubMed 7841858Farrell M. Opiate withdrawal. Addiction. 1994 Nov;89(11):1471-5. doi: 10.1111/j.1360-0443.1994.tb03745.x.
Background: PubMed 8394176Fishbain DA, Rosomoff HL, Cutler R. Opiate detoxification protocols. A clinical manual. Ann Clin Psychiatry. 1993 Mar;5(1):53-65. doi: 10.3109/10401239309148924.
Background: PubMed 21546290Heiwe 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.
Background: PubMed 18981957Mirza 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.
Background: PubMed 27105557Nguyen 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.
Background: PubMed 19919582Nilsen 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.
Individual participant dataSharing planned: No

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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.

Serena Hu, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Fusion Preoperative Opioid Taper in people with Opioid Use and Spine Fusion, run by Stanford University 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 3 inclusion and 2 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 11 Apr 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.

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?

Change in Postoperative Opioid Pain Medication Dose (time frame: Weekly, month 3, month 6). The study lists 3 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 NCT04095624, 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 11 Apr 2025.