Does Intrathecal Morphine Affect Outcomes in Spine Deformity Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Intrathecal Morphine Injection; Drug: Pain Relieving

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Recruiting
      • Sonoran Spine in Collaboration with HonorHealth
      • Contact: Biodun A Adeniyi, MBBS, MS; Phone Number: 623-683-8123; Email: biodun@sonoranspine.com
    • Tempe, Arizona, United States, 85281
      • Not yet recruiting
      • Sonoran Spine
      • Contact: Biodun Adeniyi, MBBS, MS; Phone Number: 480-597-3138

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group; Patients in this group will receive intrathecal morphine in addition to standard post-operative pain medications	Drug: Intrathecal Morphine Injection; In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group.; Other Names: Subarachnoid injection of morphine
Active Comparator: Control Group; Patients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine	Drug: Pain Relieving; Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine; Other Names: Standard Post-operative pain medications other than intrathecal morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	Preoperative
Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	6 weeks Post Operative
Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	3 months Post Operative
Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	1 year Post Operative
Pain medications	Types of pain medication (Narcotics or Non-Narcotics)	2 year Post Operative

Collaborators and Investigators

• Sponsor: Sonoran Spine Research and Education Foundation
• Investigators: Principal Investigator: Michael S Chang, MD, Sonoran Spine Research and Education Foundation; Principal Investigator: Andrew Chung, DO, Sonoran Spine Research and Education Foundation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 2, 2022
• Study Completion (Anticipated): December 2, 2023

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: SS-MSC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No