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

NCT ID: NCT02620631

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-01-31

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.

Detailed 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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Subjects receive intrathecal injection of saline at time of spinal anesthesia

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Morphine

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

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Preservative-free morphine sulfate; Preservative-free normal saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Syed Azim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Syed Azim, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medicine, Department of Anesthesia

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29486720 (View on PubMed)

Other Identifiers

200362

Identifier Type: -

Identifier Source: org_study_id