Non-pharmacological Pain Management for Post-Spine Surgery Pain

Recruiting at 3 trial locations

Overseen By Mary Laugesen, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dan Rhon

Disqualifiers: Infection, Fracture, Tumor, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

272 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Enriched Pain Management Pathway (EPM) treatment for managing pain after spine surgery?

Research suggests that a multidisciplinary approach, including non-drug methods like early mobilization and psychological support, can help manage pain after spine surgery. These components are part of enhanced recovery pathways, which have shown promise in improving postoperative outcomes. ^{1 2 3 4 5}

Is non-pharmacological pain management for post-spine surgery pain safe?

The research suggests that non-pharmacological pain management techniques, such as those used in enhanced recovery pathways, are generally safe and can help reduce the need for opioids and their side effects after surgery. However, long-term safety data is still needed to fully understand their impact on persistent pain and opioid use. ^{2 4 6 7 8}

How is the Enriched Pain Management Pathway treatment different from other treatments for post-spine surgery pain?

The Enriched Pain Management Pathway is unique because it focuses on non-drug methods like telephone counseling and nicotine replacement therapy, which are not typically part of standard care for post-spine surgery pain. This approach emphasizes a personalized, interdisciplinary plan that includes psychological support and patient education, aiming to reduce reliance on medications. ^{2 3 9 10 11}

What is the purpose of this trial?

This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.

Research Team

Daniel Rhon, PhD

Principal Investigator

Brooke Army Medical Center

Julie M Fritz, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for Tricare beneficiaries aged 18-75 who need lumbar spine surgery due to conditions like herniated discs or scoliosis and can attend treatment sessions for 16 weeks post-surgery. It's not for those with pending medical discharges, previous lumbar surgeries within a year, or conditions that limit mobility.

Inclusion Criteria

I need surgery for a spine condition like herniated disc or scoliosis.

I can attend all treatment sessions for 16 weeks after surgery without taking a 2-week break.

I need surgery for a spine condition like herniated disc or scoliosis.

Exclusion Criteria

I need surgery urgently due to infection, fracture, tumor, trauma, or another emergency.

I do not have any health issues that prevent me from joining an exercise program after surgery.

I have had a lumbar surgery or a revision in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Participants are randomized into two treatment groups prior to surgery

1 week

Post-operative Intervention

Participants receive either standard post-surgical care or enriched surgical management pathway with physical therapy and mindfulness

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to discontinuation of opioids and patient-reported outcomes

6 months

Treatment Details

Interventions

• Enriched Pain Management Pathway (EPM)
• Standard Care (SC)

Trial Overview The study compares two pain management methods after lumbar spine surgery: Standard Care (SC) versus an Enriched Pain Management Pathway (EPM). The goal is to see which one results in better patient outcomes and less opioid use. Participants are randomly assigned to one of the two groups.

Participant Groups

Group I: Standard Care (SC) Active Control 1 Intervention

Standard Post-Surgical Care utilizing opioids.

Group II: Enriched Surgical Management Pathway (EMP) Active Control 1 Intervention

Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.

Who Is Running the Clinical Trial?

Dan Rhon

Lead Sponsor

Trials

2

Recruited

390+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Madigan Army Medical Center

Collaborator

Trials

52

Recruited

17,600+

Tripler Army Medical Center

Collaborator

Trials

23

Recruited

27,900+

Findings from Research

Integrating the prescription drug monitoring program (PDMP) into the pain management workflow for elective surgery patients helps identify those on chronic opioid therapy before admission, allowing for personalized care.

This approach facilitates the development of tailored postoperative pain management plans and ensures a smooth transition back to outpatient care, enhancing patient safety and efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using drug monitoring programs to optimize pain management for elective surgery patients. Lowry, R.[2018]

An interdisciplinary approach to perioperative pain management in spine surgery is essential, considering both pharmacologic and non-pharmacologic techniques, as well as psychological factors and patient education.

While various pain management strategies, including opioids, regional anesthetics, and behavioral interventions, have shown effectiveness in the short term, further long-term studies are necessary to assess their impact on chronic pain and opioid use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Prabhakar, NK., Chadwick, AL., Nwaneshiudu, C., et al.[2022]

This study aims to systematically review and synthesize evidence for 22 individual components of an enhanced recovery pathway for spinal surgery, focusing on factors like minimally invasive techniques, multimodal pain management, and early mobilization.

The review will evaluate critical outcomes such as mortality, morbidity, patient-reported experiences, and healthcare costs, ultimately aiming to standardize care and improve recovery for spinal surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed pathway for patients undergoing enhanced recovery after spinal surgery: protocol for a systematic review. Licina, A., Silvers, A., Laughlin, H., et al.[2023]

Fast-track surgery (FTS) combined with specialized pain care significantly reduces postoperative pain and complications in spinal surgery patients, as shown by lower numeric rating scale (NRS) scores and reduced adverse effects compared to standard care.

Patients receiving the combined FTS and pain care intervention experienced faster recovery times, including shorter time to get out of bed and reduced length of hospital stay, along with higher nursing satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Fast-Track Surgery with Pain Care on Postoperative Pain Improvement and Complication Prevention in Perioperative Spine Surgery Patients. Xie, G., Liu, F., Fan, L., et al.[2022]

A national care pathway for managing low back pain and radicular pain was developed in Belgium, integrating insights from 11 international pathways and 7 local initiatives, emphasizing the importance of multidisciplinary teamwork.

The pathway was constructed through a consensus approach involving various healthcare professionals and is based on established guidelines, making it a practical tool for caregivers and patients in Belgium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pivotal role for the multidisciplinary approach at all phases and at all levels in the national pathway for the management of low back pain and radicular pain in Belgium. Depreitere, B., Jonckheer, P., Coeckelberghs, E., et al.[2020]

The IMPAKT ERAS trial is a large-scale study involving 1544 patients undergoing major abdominal surgery to evaluate the impact of perioperative ketamine infusions on functional recovery and opioid consumption within Enhanced Recovery After Surgery (ERAS) pathways.

This pragmatic, randomized, placebo-controlled trial aims to determine if adding ketamine to the multimodal analgesic regimen can reduce hospital length of stay and improve clinical outcomes, potentially enhancing recovery while minimizing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. Raymond, BL., Allen, BFS., Freundlich, RE., et al.[2023]

In a study of 236 patients undergoing elective laparotomy, the use of epidural analgesia (EA) did not significantly reduce overall postoperative opioid consumption compared to those who did not receive EA.

Interestingly, patients with EA had higher opioid use on postoperative day three, suggesting that EA may not provide the expected benefits in reducing opioid requirements after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of epidural analgesia on postoperative opioid requirements following elective laparotomies performed at Vancouver General Hospital. Leung, P., Albarrak, AA., Rahavi, A., et al.[2021]

The IMPAKT ERAS trial is a large-scale study involving 1544 patients undergoing major abdominal surgery, investigating the effects of perioperative ketamine infusions on functional recovery and opioid consumption within Enhanced Recovery After Surgery (ERAS) pathways.

This pragmatic, randomized, placebo-controlled trial aims to determine if adding ketamine to standard multimodal analgesic regimens can reduce hospital length of stay and improve clinical outcomes, potentially enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. Raymond, BL., Allen, BFS., Freundlich, RE., et al.[2023]

A rapid recovery pathway (RRP) for adolescent idiopathic scoliosis patients undergoing spinal fusion surgery significantly reduced opioid consumption in the first two postoperative days, with a mean difference of 61.6 morphine milligram equivalents (MME) compared to traditional methods.

Patients in the RRP group also experienced a shorter hospital stay, averaging 2.5 days compared to 4.0 days for those receiving epidural catheter analgesia, indicating that the RRP can effectively accelerate recovery without compromising pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid recovery pathway without epidural catheter analgesia for surgical treatment of adolescent idiopathic scoliosis: a comparative study. Colón, LF., Powell, C., Wilson, A., et al.[2023]

In a systematic review of 86 randomized controlled studies involving 6284 participants, triple-drug therapy (paracetamol, nonsteroidal anti-inflammatory drugs, and an adjunct) was found to be the most effective pain management strategy for adult spine surgery, significantly reducing morphine consumption by an average of 26 mg and pain scores by 2.3 points at 24 hours post-surgery.

The analysis demonstrated that the effectiveness of pain relief interventions increased with the number of drugs used, highlighting the importance of multimodal approaches in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of perioperative pharmacological and regional pain interventions in adult spine surgery: a network meta-analysis and systematic review of randomised controlled trials. Bae, S., Alboog, A., Esquivel, KS., et al.[2022]

Enhanced recovery pathways are structured programs that use evidence-based interventions to standardize surgical techniques, improve patient outcomes, and reduce hospital costs, including facilitating earlier discharges after surgery.

Despite their proven benefits and 20-year history, many clinical teams have yet to adopt these pathways, highlighting the need for increased outreach and formal guidelines to promote their implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evolution of Surgical Enhanced Recovery Pathways: a Review. Elhassan, A., Ahmed, A., Awad, H., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using drug monitoring programs to optimize pain management for elective surgery patients. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Proposed pathway for patients undergoing enhanced recovery after spinal surgery: protocol for a systematic review. [2023]

4. Egypt pubmed.ncbi.nlm.nih.gov

Analysis of Fast-Track Surgery with Pain Care on Postoperative Pain Improvement and Complication Prevention in Perioperative Spine Surgery Patients. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

The pivotal role for the multidisciplinary approach at all phases and at all levels in the national pathway for the management of low back pain and radicular pain in Belgium. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of epidural analgesia on postoperative opioid requirements following elective laparotomies performed at Vancouver General Hospital. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Rapid recovery pathway without epidural catheter analgesia for surgical treatment of adolescent idiopathic scoliosis: a comparative study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of perioperative pharmacological and regional pain interventions in adult spine surgery: a network meta-analysis and systematic review of randomised controlled trials. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The Evolution of Surgical Enhanced Recovery Pathways: a Review. [2019]