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Trial record 87 of 326 for:    clonidine

Addition of Clonidine to Ropivacaine in Adductor Canal Block

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ClinicalTrials.gov Identifier: NCT03057015
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Borzoo Farhang, University of Vermont

Brief Summary:

Total knee arthroplasty (knee replacement) is a common orthopedic procedure for osteoarthritis. This procedure is performed either under general anesthesia or spinal anesthesia; after the procedure in the recovery room, these patients undergo adductor canal block, which is a nerve block to provide 8-14 hours of postoperative pain control. For this nerve block, 15-20 ml of local anesthetic is combined with adjuvant medications to improve the quality of pain control as well as the duration of pain relief. The primary local anesthetic used for adductor canal block is ropivacaine, and the commonly used adjuvants are epinephrine and dexamethasone.

There is conflicting data available in the literature regarding efficacy of addition of clonidine to the local anesthetic injection in peripheral nerve blocks, and there is no data assessing the efficacy of this medication in adductor canal blocks.

Once the consent process is completed, patients are enrolled in two arms. Upon conclusion of surgery, a sealed and coded envelope with either clonidine or the placebo syringe will be given to the acute pain service staff performing the nerve block. This will be mixed with local anesthetic solution and injected in the adductor canal under ultrasound guidance.

The primary outcome measure will be the duration of analgesia, which will be assessed as the time interval between placement of adductor canal block to the first request of opioid analgesic by patients (which will be obtained from hospital electronic medical records). Secondary outcomes will include:

  1. Duration of sensory block, which will be assessed as the time interval between injection of local anesthetic and report of postoperative pain of 3 or more on an 11 point scale (0=no pain; 10= worst pain imaginable) by the patient (this will be assessed every 4 hours).
  2. Duration of motor block, which will be assessed as the time interval between the onset of motor block to complete recovery of motor block by assessing straight leg raise strength (this will be assessed every 4 hours).
  3. Cumulative 24 and 48 hour opioid analgesic use.
  4. Post-block pain scores, evaluated by an 11 point pain score (0-10), which will be done every 15 minutes for the first hour after surgery and every 4 hours thereafter for 24 hours.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Clonidine Drug: Placebo Drug: Ropivacaine Drug: Dexamethasone Drug: Epinephrine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Addition of Clonidine to Ropivacaine in Adductor Canal Block for Postoperative Pain Relief in Total Knee Arthroplasty: A Prospective Randomized Double Blind Placebo Controlled Trial
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clonidine
50 mcg clonidine + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution
Drug: Clonidine
50 mcg Clonidine added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the treatment group.

Drug: Ropivacaine
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.

Drug: Dexamethasone
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.

Drug: Epinephrine
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.

Placebo Comparator: Placebo
0.5 ml normal saline + 0.5% ropivacaine + 2 mg dexamethasone + 5 mcg/ml epinephrine in 20 ml solution
Drug: Placebo
Normal saline added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the placebo group.

Drug: Ropivacaine
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.

Drug: Dexamethasone
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.

Drug: Epinephrine
Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.




Primary Outcome Measures :
  1. Duration of Analgesia [ Time Frame: 24 hours for primary outcome ]
    the time interval between placement of adductor canal block to the first request of opioid analgesic by patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women ages 18 and older
  • ASA physical status classification system I, II and III (healthy patient or patient with mild to moderate systemic disease)
  • Patient coming in for elective total knee arthroplasty under general or neuraxial anesthesia and postoperative adductor canal block
  • Patients staying for at least 24 hrs post operatively
  • Patients who provide informed consent
  • Patients presenting for surgery >1 hour in length and <6 hours.

Exclusion Criteria:

  • History of recent common colds, upper respiratory infections or immune deficiencies
  • Patients allergic to clonidine
  • Pregnant women (all women of childbearing age undergo pregnancy testing prior to anesthesia as per UVMMC peri-operative protocol)
  • Patients who are already on chronic clonidine therapy for management of blood pressure
  • Patients on chronic opioid therapy defined as more than 10 mg of oxycodone per day (or equivalent doses of other opioid analgesics)

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): NCT03057015


Contacts
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Contact: Borzoo Farhang, DO 8028819927 borzoo.farhang@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Borzoo Farhang, DO    802-881-9927    borzoo.farhang@uvmhealth.org   
Principal Investigator: Borzoo Farhang, DO         
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Borzoo Farhang, DO University of Vermont Medical Center

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Responsible Party: Borzoo Farhang, Clinical Instructor of Anesthesiology, University of Vermont
ClinicalTrials.gov Identifier: NCT03057015     History of Changes
Other Study ID Numbers: CHRMS 17-0107
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Clonidine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Epinephrine
Racepinephrine
Ropivacaine
Pharmaceutical Solutions
Epinephryl borate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local