Study to Examine Pain Relief With Supplemental Intrathecal Morphine in TKA Patients

Acute Pain Clinical Trial

Official title:

Prospective, Randomized, Double-blinded, Placebo-controlled Study to Examine Pain Relief and the Need for Supplementary Analgesics With Intra-thecal Morphine Sulfate (0.2 mg) in Patients Undergoing Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02620631
• Other study ID #: 200362
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 1, 2015
• Last updated: December 1, 2015
• Start date: March 2011
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, case-controlled randomized, double-blinded, placebo-controlled study expected to enroll up to 100 patients scheduled to undergo unilateral total knee arthroplasty (TKA) under regional anesthesia (defined as intrathecal spinal + femoral nerve blockade + femoral nerve catheter for post-operative analgesia) at Stony Brook Hospital. The patients were randomized to receive either IT morphine 0.2 mg (Group 1) or placebo (Group 2) in combination with their standard-of-care spinal anesthesia. Post-operatively, the patients were given an intravenous patient-controlled analgesic opioid for breakthrough pain.

Only the pharmacist preparing the drug/placebo has knowledge of how each subject was randomized. Study staff completed multiple questionnaires regarding subjects' pain scores and patient disability from pain to assess changes between different study periods (ie. pre-operative, post-operative and follow up). Biological samples were also taken from each subject to measure and analyze differences and changes in endocannabinoid levels.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: January 2017
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Scheduled for unilateral TKA under regional anesthesia

• ASA Class 1, 2 or 3

• Able to give informed consent

• Able to understand English

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Morphine
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
• Placebo
Subjects receive intrathecal, preservative-free normal saline pre-operatively in conjunction with post-operative PCA morphine

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute pain at rest	Numerical rating scale pain scores were collected every 4 hours	0-24 hours
Secondary	Total opioids dispensed	Total dosage of opioids (in morphine equivalent doses) measured over 24 hours	0-24 hours