Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Nursing staff and physical therapists will be blinded to intrathecal morphine utilization as to not bias the input of these variables

Study Groups

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Study Group

Patients in this group will receive intrathecal morphine in addition to standard post-operative pain medications

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine Injection

Intervention Type DRUG

In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.

Control Group

Patients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine

Group Type ACTIVE_COMPARATOR

Pain Relieving

Intervention Type DRUG

Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine

Interventions

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Intrathecal Morphine Injection

In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.

Intervention Type DRUG

Pain Relieving

Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine

Intervention Type DRUG

Other Intervention Names

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Subarachnoid injection of morphine Standard Post-operative pain medications other than intrathecal morphine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes