Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery

Low Back Pain Clinical Trial

Official title:

Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery: A Prospective, Randomized Clinical Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092828
• Other study ID #: SS-MSC-001
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: December 2, 2023

Study information

• Verified date: May 2022
• Source: Sonoran Spine Research and Education Foundation
• Contact: Biodun Adeniyi, MBBS, MS
• Phone: 4805973138
• Email: biodun[@]sonoranspine.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Drug:
• Intrathecal Morphine Injection
In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.
• Pain Relieving
Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine

Locations

Country	Name	City	State
United States	Sonoran Spine	Tempe	Arizona
United States	Sonoran Spine in Collaboration with HonorHealth	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sonoran Spine Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Outcome Assessment	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain Oswesty Disability Index and Scoliosis Research Society Questionnaire	preoperative
Primary	Pain and Outcome Assessment	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain	6 week, post operative
Primary	Pain and Outcome Assessment	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain	3 months post operative
Primary	Pain and Outcome Assessment	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain	1 year post operative
Primary	Pain and Outcome Assessment	postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain	2-year follow up
Secondary	Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	Preoperative
Secondary	Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	6 weeks Post Operative
Secondary	Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	3 months Post Operative
Secondary	Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	1 year Post Operative
Secondary	Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	2 year Post Operative