NCT05092828

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 low-back-pain

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

September 16, 2021

Last Update Submit

May 9, 2022

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (5)

  • 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

  • Pain and Outcome Assessment

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    6 week, post operative

  • Pain and Outcome Assessment

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    3 months post operative

  • Pain and Outcome Assessment

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    1 year post operative

  • Pain and Outcome Assessment

    postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain

    2-year follow up

Secondary Outcomes (5)

  • Pain medications

    Preoperative

  • Pain medications

    6 weeks Post Operative

  • Pain medications

    3 months Post Operative

  • Pain medications

    1 year Post Operative

  • Pain medications

    2 year Post Operative

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Drug: Intrathecal Morphine Injection

Control Group

ACTIVE COMPARATOR

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

Drug: Pain Relieving

Interventions

Intrathecal Morphine InjectionDRUG

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

Also known as: Subarachnoid injection of morphine
Study Group
Pain RelievingDRUG

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

Also known as: Standard Post-operative pain medications other than intrathecal morphine
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sonoran Spine in Collaboration with HonorHealth

Tempe, Arizona, 85281, United States

RECRUITING

Sonoran Spine

Tempe, Arizona, 85281, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Michael S Chang, MD

    Sonoran Spine Research and Education Foundation

    PRINCIPAL INVESTIGATOR

  • Andrew Chung, DO

    Sonoran Spine Research and Education Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Biodun Adeniyi, MBBS, MS

CONTACT

4805973138biodun@sonoranspine.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Nursing staff and physical therapists will be blinded to intrathecal morphine utilization as to not bias the input of these variables
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 26, 2021

Study Start

December 1, 2021

Primary Completion

December 2, 2022

Study Completion

December 2, 2023

Last Updated

May 13, 2022

Record last verified: 2022-05

Locations

US(2)