Trial Outcomes & Findings for Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery (NCT NCT04990804)

Results Overview

Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively)

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

9-12 months

Results posted on

2024-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Perioperative Pain Regimen Opioid Analgesic: Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.	Opioid-Free Perioperative Pain Regimen Opioid-Free Postoperative Pain Regimen: Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
Overall Study STARTED	5	3
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Perioperative Pain Regimen n=5 Participants Opioid Analgesic: Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.	Opioid-Free Perioperative Pain Regimen n=3 Participants Opioid-Free Postoperative Pain Regimen: Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=3 Participants	6 Participants n=8 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=3 Participants	2 Participants n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=3 Participants	6 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=3 Participants	2 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=3 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 9-12 months

Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.

Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Postoperative day 1, 7, 14

Population: One participant in the Standard Perioperative Pain Regimen group was lost to follow-up after randomization. One participant in the Opioid-Free Perioperative Pain Regimen group was lost to follow-up after randomization.

Numeric Rating Scale (NRS) arm pain and neck pain scores. This scale grades pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The higher the pain score, the more ineffective a patient's pain medication regimen is.

Outcome measures

Outcome measures
Measure	Standard Perioperative Pain Regimen n=4 Participants Opioid Analgesic: Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.	Opioid-Free Perioperative Pain Regimen n=2 Participants Opioid-Free Postoperative Pain Regimen: Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
Postoperative Pain Current Neck Pain Day 1	4.0 score on a scale Standard Deviation 2.9	1.5 score on a scale Standard Deviation 0.7
Postoperative Pain Current Neck Pain Day 7	4.2 score on a scale Standard Deviation 2.4	0.0 score on a scale Standard Deviation 0.0
Postoperative Pain Current Neck Pain Day 14	2.0 score on a scale Standard Deviation 3.4	4.0 score on a scale
Postoperative Pain Average Neck Pain Day 1	5.5 score on a scale Standard Deviation 4.1	1.5 score on a scale Standard Deviation 0.7
Postoperative Pain Average Neck Pain Day 7	5.3 score on a scale Standard Deviation 3.6	0.0 score on a scale Standard Deviation 0.0
Postoperative Pain Average Neck Pain Day 14	3.8 score on a scale Standard Deviation 3.3	1.5 score on a scale Standard Deviation 2.1
Postoperative Pain Current Arm Pain Day 1	2.5 score on a scale Standard Deviation 5.0	0.5 score on a scale Standard Deviation 0.7
Postoperative Pain Current Arm Pain Day 7	1.8 score on a scale Standard Deviation 3.5	1.5 score on a scale Standard Deviation 0.7
Postoperative Pain Current Arm Pain Day 14	1.8 score on a scale Standard Deviation 3.5	3.0 score on a scale Standard Deviation 1.4
Postoperative Pain Average Arm Pain Day 1	0.5 score on a scale Standard Deviation 0.7	3.0 score on a scale Standard Deviation 4.8
Postoperative Pain Average Arm Pain Day 7	1.0 score on a scale Standard Deviation 0.0	1.8 score on a scale Standard Deviation 3.5
Postoperative Pain Average Arm Pain Day 14	2.5 score on a scale Standard Deviation 0.7	2.0 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: 3 and 12 months postoperatively

Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.

A disease non-specific tool for measuring medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and phsyical functioning. Each domain contains questions specific to what trait is being measure. Scores have a mean of 50 and a standard deviation of 10. The higher the score, the better the outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 and 12 months postoperatively

Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 and 12 months postoperatively

Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 and 12 months postoperatively

Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.

Ask the patient how satisfied they are will their surgical treatment and includes the following responses. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.

Readmissions, adverse events, serious adverse events

Outcome measures

Outcome data not reported

Adverse Events

Standard Perioperative Pain Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Opioid-Free Perioperative Pain Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Vanderbilt University Medical Center

Phone: 615-936-7107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place