Intrathecal Morphine Versus Epidural Extended Release Morphine for

Status Completed

Clinical Trial Summary

This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children.

Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.

Clinical Trial Description

Up to 80 people from Denver will participate in the study. Subjects will be randomized to receive one of two possible medications during surgery to help with pain after surgery. After they go to sleep for surgery the anesthesiologist will give them either (1) a single injection of morphine into the spinal fluid in the lower back, or (2) a single injection of extended-release morphine into the epidural space (just outside the spinal fluid) in the lower back.

The usual care for patients having this surgery is a single injection of morphine into the spinal fluid in the lower back. If randomized to group (1), subjects will receive the usual care for pain control. If subjects are randomized to group (2), they will receive a single injection of extended-release morphine into the epidural space.

During surgery, a small blood sample (1 teaspoon or less) will be collected to analyze specific DNA sequences that are involved in individual responses to morphine for pain control. The blood sample will be destroyed after 24 months.

After surgery, subjects will have IV pain medication through a patient-controlled analgesia (PCA) machine. Subjects will be shown how to work the PCA so they can get the pain medicine when they need it. A research nurse will check in frequently to ask how much pain is occurring following the surgery and any side effects that may arise from the study medicine.

Subjects will be in this study up to 60 hours after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00880607
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Completed
Phase	Phase 4
Start date	December 2008
Completion date	September 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03334929` - Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic	N/A
Recruiting	`NCT06129383` - The Effect of Adding PIFP Block to SAP Block on Postoparative Pain Management in Patient Planned for Breast Surgery	N/A
Completed	`NCT06054945` - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Active, not recruiting	`NCT02276495` - Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?	N/A
Completed	`NCT04094246` - Battlefield Acupuncture Following Shoulder Surgery	N/A
Completed	`NCT05514236` - Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopy	N/A
Recruiting	`NCT04809935` - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy	Phase 4
Not yet recruiting	`NCT05492903` - COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)	N/A
Not yet recruiting	`NCT04328805` - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.	Phase 4
Completed	`NCT02922101` - Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care	N/A
Completed	`NCT01541293` - Intrauterine Lidocaine for Laminaria	Phase 1
Not yet recruiting	`NCT01059487` - Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine	Phase 0
Completed	`NCT03290378` - Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy	Phase 3
Recruiting	`NCT05794828` - Erector Spinae Regional Anesthesia for Pain Control	Early Phase 1
Active, not recruiting	`NCT04109885` - Paracervical Injection for Headache in the Emergency Department	Phase 2
Recruiting	`NCT05857202` - Oxidative Stress and Inflammation Biomarkers in Surgically Treated Patients With Laryngeal Cancer
Recruiting	`NCT03851042` - Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy	N/A
Completed	`NCT04566536` - NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery
Completed	`NCT03471390` - Improving Pain Management in Nursing Homes: a Pilot Study	N/A
Enrolling by invitation	`NCT02995278` - Usage and Plan of Care Changes Due to Drug Screenings

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms