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Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intrathecal Morphine Injection
Pain Relieving
Sponsored by
Sonoran Spine Research and Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sonoran Spine in Collaboration with HonorHealthRecruiting
  • Sonoran Spine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Pain and Outcome Assessment
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

Secondary Outcome Measures

Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)
Pain medications
Types of pain medication (Narcotics or Non-Narcotics)

Full Information

First Posted
September 16, 2021
Last Updated
May 9, 2022
Sponsor
Sonoran Spine Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05092828
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sonoran Spine Research and Education Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Nursing staff and physical therapists will be blinded to intrathecal morphine utilization as to not bias the input of these variables
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive intrathecal morphine in addition to standard post-operative pain medications
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine Injection
Other Intervention Name(s)
Subarachnoid injection of morphine
Intervention Description
In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.
Intervention Type
Drug
Intervention Name(s)
Pain Relieving
Other Intervention Name(s)
Standard Post-operative pain medications other than intrathecal morphine
Intervention Description
Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine
Primary Outcome Measure Information:
Title
Pain and Outcome Assessment
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain Oswesty Disability Index and Scoliosis Research Society Questionnaire
Time Frame
preoperative
Title
Pain and Outcome Assessment
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
6 week, post operative
Title
Pain and Outcome Assessment
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
3 months post operative
Title
Pain and Outcome Assessment
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
1 year post operative
Title
Pain and Outcome Assessment
Description
postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain
Time Frame
2-year follow up
Secondary Outcome Measure Information:
Title
Pain medications
Description
Types of pain medication (Narcotics or Non-Narcotics)
Time Frame
Preoperative
Title
Pain medications
Description
Types of pain medication (Narcotics or Non-Narcotics)
Time Frame
6 weeks Post Operative
Title
Pain medications
Description
Types of pain medication (Narcotics or Non-Narcotics)
Time Frame
3 months Post Operative
Title
Pain medications
Description
Types of pain medication (Narcotics or Non-Narcotics)
Time Frame
1 year Post Operative
Title
Pain medications
Description
Types of pain medication (Narcotics or Non-Narcotics)
Time Frame
2 year Post Operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biodun Adeniyi, MBBS, MS
Phone
4805973138
Email
biodun@sonoranspine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Chang, MD
Organizational Affiliation
Sonoran Spine Research and Education Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Chung, DO
Organizational Affiliation
Sonoran Spine Research and Education Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonoran Spine in Collaboration with HonorHealth
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biodun A Adeniyi, MBBS, MS
Phone
623-683-8123
Email
biodun@sonoranspine.com
Facility Name
Sonoran Spine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biodun Adeniyi, MBBS, MS
Phone
480-597-3138

12. IPD Sharing Statement

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Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery

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