Clinical trial NCT05092828: Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery
Official title: Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery: A Prospective, Randomized Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Sonoran Spine Research and Education Foundation
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.

Detailed description: Background Deformity surgery is considered one of the most painful procedures patients can undergo in medicine today. Stringent protocols for pain management have done much to dramatically increase patient satisfaction, but the procedure still lags considerably behind advances in pain control when compared to other procedures such as total joint surgery. Specifically, it has been reported that over half of patients undergoing spine surgery report inadequate pain control the first 24 hours after surgery. Uncontrolled pain has been shown to correlate with prolonged hospital stays, delayed ambulation, poor functional outcomes, and increased risk for the development of chronic pain. Furthermore, the large amount of narcotics given to patients in an attempt to mitigate their pain postoperatively often leads to significant complications in their own right, such as ileus, mental status changes, and nausea. New modalities to treat postoperative pain, especially in the initial days following deformity correction, are needed.

Intrathecal (subarachnoid) injection of morphine has been used to treat severe pain since the 1970's. Its efficacy in treating postoperative pain has been well documented in various specialties including obstetrics, oncology, general surgery, and orthopedic surgery. Specific to spine surgery, intrathecal morphine is an attractive option given the access and visualization of the thecal sac in addition to the high demand of pain control required postoperatively. However, there remains no definitive consensus regarding the use of intrathecal morphine in spine surgery. Current literature is limited by few randomized trials, small sample sizes, heterogeneity of outcomes recorded, and an unclear association with complications. Additionally, there is a paucity of data dedicated to patients undergoing deformity correction. Accordingly, there is a need for high-quality trials to investigate the role of intrathecal morphine in adult spinal deformity surgery.

In this study, we hypothesized that the use of intrathecal morphine will significantly reduce post-operative pain after deformity surgery, reduce opioid utilization, decrease hospital stay, allow for earlier ambulation, increase patient satisfaction, and have comparable complications to traditional pain management strategies. This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years and older with a diagnosis of adult or degenerative scoliosis,
* Patients meeting criteria for surgical correction involving back and/or leg pain
* Fusion of 4+ levels,
* Competency to undergo informed consent process,
* Medical clearance for spinal fusion surgery,

Exclusion Criteria:

* Patients with lumbar spine inaccessible for intrathecal Duragesic (fused L2-S1)
* Patients undergoing 3 or less levels of fusion
* Patients with neuromuscular disease
* Opioid intolerance or dependence
* Severe coexisting diseases
* ASA III

Primary outcomes:
measure: Pain and Outcome Assessment
timeFrame: preoperative
measure: Pain and Outcome Assessment
timeFrame: 6 week, post operative
measure: Pain and Outcome Assessment
timeFrame: 3 months post operative
measure: Pain and Outcome Assessment
timeFrame: 1 year post operative
measure: Pain and Outcome Assessment
timeFrame: 2-year follow up
Secondary outcomes:
measure: Pain medications
timeFrame: Preoperative
measure: Pain medications
timeFrame: 6 weeks Post Operative
measure: Pain medications
timeFrame: 3 months Post Operative
measure: Pain medications
timeFrame: 1 year Post Operative
measure: Pain medications
timeFrame: 2 year Post Operative
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Sonoran Spine in Collaboration with HonorHealth
state: Arizona
city: Tempe
country: United States
facility: Sonoran Spine
state: Arizona
Study officials:
affiliation: Sonoran Spine Research and Education Foundation
name: Michael S Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sonoran Spine Research and Education Foundation
name: Andrew Chung, DO
role: PRINCIPAL_INVESTIGATOR
References: