NCT02620631

Brief Summary

This is a prospective, randomized, double-blinded, placebo-controlled study designed to examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve catheter. The protocol consists of two parts: (1) a prospective patient recruitment study and (2) a retrospective assay for endocannabinoids on previously collected specimens.

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
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

December 1, 2015

Last Update Submit

December 1, 2015

Conditions

Acute Pain

Keywords

MorphineTKAPainTKRArthroplasty

Outcome Measures

Primary Outcomes (1)

  • Acute pain at rest

    Numerical rating scale pain scores were collected every 4 hours

    0-24 hours

Secondary Outcomes (1)

  • Total opioids dispensed

    0-24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects receive intrathecal injection of saline at time of spinal anesthesia

Drug: Placebo

Morphine

EXPERIMENTAL

Subjects receive intrathecal injection of morphine sulfate 0.2mg at time of spinal anesthesia

Drug: Morphine

Interventions

MorphineDRUG

Subjects receive intrathecal morphine pre-operatively to determine its level of efficacy in acute pain control post-operatively when used in conjunction with post-operative PCA morphine

Also known as: Preservative-free morphine sulfate
Morphine
PlaceboDRUG

Subjects receive intrathecal, preservative-free normal saline pre-operatively in conjunction with post-operative PCA morphine

Also known as: Preservative-free normal saline
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for unilateral TKA under regional anesthesia
  • ASA Class 1, 2 or 3
  • Able to give informed consent
  • Able to understand English

You may not qualify if:

  • Medical condition(s) that prevents use of regional anesthesia (e.g. infection at site of injection, coagulopathy, severe hypovolemia, severe aortic or mitral stenosis, increased intracranial pressure, severe spinal deformity, spinal cord hardware or stimulator implanted)
  • Allergy to morphine
  • Morbid obesity (BMI \> 45)
  • Respiratory compromise (difficult airway, severe emphysema or COPD)
  • Obstructive sleep apnea (only if diagnosed in a sleep disorders clinic and CPAP was prescribed)
  • Chronic pain with opioid usage over 100 mg morphine-equivalents po/day
  • History of abuse of opioids or other drugs of abuse
  • Scheduled for bilateral TKA
  • Revision of knee arthroplasty
  • Any medical condition that would affect the patient's ability to metabolize or excrete the study drugs (e.g. chronic kidney failure with patient on dialysis) or other medical condition that in the investigator's opinion would render the patient unsuitable for this research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • Kaczocha M, Azim S, Nicholson J, Rebecchi MJ, Lu Y, Feng T, Romeiser JL, Reinsel R, Rizwan S, Shodhan S, Volkow ND, Benveniste H. Intrathecal morphine administration reduces postoperative pain and peripheral endocannabinoid levels in total knee arthroplasty patients: a randomized clinical trial. BMC Anesthesiol. 2018 Feb 27;18(1):27. doi: 10.1186/s12871-018-0489-5.

    PMID: 29486720DERIVED

MeSH Terms

Conditions

Acute PainPain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Syed Azim, MD

    Stony Brook Medicine, Department of Anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

March 1, 2011

Primary Completion

February 1, 2014

Study Completion

January 1, 2017

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)