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Trial record 58 of 326 for:    clonidine

Intra-articular Morphine and Clonidine Injections for Pain Management in Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT02530151
Recruitment Status : Completed
First Posted : August 20, 2015
Results First Posted : May 20, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Terry, Northwestern University

Brief Summary:
The purpose of this study is to determine whether intraoperative (during surgery) morphine and clonidine hip injections are effective in postoperative pain management for patients undergoing hip arthroscopy.

Condition or disease Intervention/treatment Phase
Femoracetabular Impingement Pain, Postoperative Drug: Morphine with clonidine Other: Normal saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Prospective Assessment of Intraoperative Intra-articular Morphine and Clonidine Injection in Hip Arthroscopy on Postoperative Pain Management
Study Start Date : November 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morphine with Clonidine
11 mL intra-articular injection of 10 mg morphine and 100 mcg clonidine in .9% NaCl solution at conclusion of hip arthroscopy procedure
Drug: Morphine with clonidine
see arm description

Placebo Comparator: Normal Saline
11 mL intra-articular injection of .9% NaCl solution at conclusion of hip arthroscopy procedure
Other: Normal saline
see arm description




Primary Outcome Measures :
  1. Opioid Consumption in the Acute Postoperative Period [ Time Frame: Recorded intraoperatively, during PACU stay, 6 hours post discharge, 18 hours post discharge, 24 hours post discharge, 48 hours post discharge, and at 7 days post discharge ]
    The total usage of opioid medication (mEq) for pain relief in the intraoperative period and again through the postoperative recovery period from arrival in the PACU through 7 days post op


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) Pain Scores [ Time Frame: Immediately preoperative (5-10 minutes before surgery), immediately postoperative (5-10 minutes after surgery), 1 hr post operatively ]
    Patients will rate their pain (0-10) on the Visual Analog Scale with higher scores for the VAS indicated elevated pain intensity reported by the patient for the indicated time point

  2. Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery [ Time Frame: Preoperative to 24 hrs. post operatively ]
    The Quality of Recovery questionnaire (QoR-15) is a 15 question patient reported outcome measure used to evaluate the quality of recovery following surgical anesthesia concerning pain, physical function, and psychological factors; reported as a summative score with each question graded between 0-10 (Range:0-150) with higher scores indicating improved physical/psychological recovery or infrequent symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient undergoing a hip arthroscopy procedure for femoracetabular impingement by the senior surgeon (M.T.)

Exclusion Criteria:

  • Morphine contraindication
  • Clonidine contraindication
  • Pregnant women
  • Prisoners
  • Adults unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530151


Locations
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United States, Illinois
Joshua Barett
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Michael Terry, MD Northwestern University
  Study Documents (Full-Text)

Documents provided by Michael Terry, Northwestern University:
Informed Consent Form  [PDF] October 30, 2015


Publications:
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Responsible Party: Michael Terry, Associate Professor in Orthopaedic Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02530151     History of Changes
Other Study ID Numbers: STU00201218
First Posted: August 20, 2015    Key Record Dates
Results First Posted: May 20, 2019
Last Update Posted: September 23, 2019
Last Verified: September 2019
Keywords provided by Michael Terry, Northwestern University:
Hip arthroscopy
Intra-articular injection
Morphine
Clonidine
Additional relevant MeSH terms:
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Clonidine
Femoracetabular Impingement
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action