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The Effect of Ongoing Beta-blockers Administration on Analgesic Requirements in the Immediate Perioperative Period.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498898
Recruitment Status : Unknown
Verified April 2018 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : April 17, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
This study is designed to discover if chronic use of Beta adrenergic receptor blockers affects pain sensation during and after an elective procedure of hip or knee replacement. The study's population will be divided to four groups: Group A- chronic use of Beta adrenergic receptor blockers undergoing total hip replacement, Group B- no use of Beta adrenergic receptor blockers undergoing total hip replacement, Group C- chronic use of Beta adrenergic receptor blockers undergoing total knee replacement and Group D- no use of Beta adrenergic receptor blockers undergoing total knee replacement. Each patient will be anesthetized using the same anesthesia protocol with pain assessment done by the ANI device intra operatively and by NRS score postoperatively.

Condition or disease Intervention/treatment Phase
Nociceptive Pain Other: Chronic use of Beta adrenergic receptor blocker Not Applicable

Detailed Description:

The effect of ongoing Beta adrenergic receptor blockers administration on perioperative and post-operative pain.

Beta adrenergic receptor blockers are in common use for treatment of a variety of illnesses. Mostly ones that are connected to the cardiovascular system (such as congestive heart failure, angina pectoris and dysrhythmias) but also for treatment of some neurological disorders and more.

Esmolol and Labetalol are frequently utilized during the perioperative period because of their beneficial effects in treating the acute hemodynamic response to surgical stress. However, clinical studies have confirmed that these adjuvant drugs can reduce postoperative opioid consumption and facilitate earlier extubation. In multiple studies, Esmolol was found effective reducing postoperative pain and the need for narcotic analgesics following surgery. A Meta-analysis published in 2015 in the Journal of Anesthesiology found that Esmolol caused a 32-50% reduction in the need for rescue analgesics and that propranolol decreased the need for rescue analgesics by 72%.

The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates heart rate variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart . A painful stimulus will cause a relative decrease in parasympathetic tone and therefore result in a decrease in ANI scores. A score of 100 indicates maximum parasympathetic tone and low nociceptive levels, while a score of zero indicates minimum parasympathetic tone and high nociceptive levels. ANI has been validated in a few studies. In a recently published clinical trial comparing ANI to other predictive modalities and to traditional clinical signs (heart rate and mean arterial pressure) ANI was found to have the highest sensitivity and specificity (P k -0.98) for detecting painful stimulations.

The NRS for pain is a unidimensional measure of pain intensity in adults. The most commonly used is the 11-item NRS which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain where 0 is described as no pain and 10 is described as the worst pain imaginable. The NRS-11 is perhaps the most commonly used pain intensity rating tool with a highly correlated validity to the visual analogue scale (VAS). In addition High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r 0.96 and 0.95, respectively).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Ongoing Beta-blockers Administration on Analgesic Requirements in the Immediate Perioperative Period.
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement
Other: Chronic use of Beta adrenergic receptor blocker
Chronic use of Beta adrenergic receptor blocker

No Intervention: Group B
American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement
Active Comparator: Group C
American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement.
Other: Chronic use of Beta adrenergic receptor blocker
Chronic use of Beta adrenergic receptor blocker

No Intervention: Group D
American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement



Primary Outcome Measures :
  1. Fentanyl consumption during surgery. [ Time Frame: Intra operative (anaesthesia start until anaesthesia end). ]
    Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Fentanyl).


Secondary Outcome Measures :
  1. Post operative Morphine consumption. [ Time Frame: Immediate post operative time (from admission to release from PACU). ]
    Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Morphine).

  2. Post operative non opioid analgesia consumption. [ Time Frame: Immediate post operative time (from admission to release from PACU). ]
    Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of non opioid analgesia.

  3. Post operative pain (NRS score). [ Time Frame: 15 minutes after admission to PACU. ]
    Measuring the effect of chronic use of Beta adrenergic receptor blockers on NRS pain score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Candidates for an elective hip replacement.

Exclusion Criteria:

  • Patients with no sinus rhythm.
  • Patients with an internal cardiac device / cardiac pacemaker.
  • The use of Anti muscarinic, alpha adrenergic receptor blockers or anti arhythmic medications.
  • Chronic use of Opioids (defined as 20 mg or more of Oxycodone per day for a period of 6 weeks or more).
  • BMI> 40.
  • Sensitivity to one of the following drugs: Propofol, Fentanyl, Rocuronium, Isoflurane, Morphine, Acetaminophen, Ondansetron.

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): NCT03498898


Contacts
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Contact: Idit Matot, MD, PhD 97236974758 iditm@tlvmc.gov.il
Contact: Miri Davidovich 97236974758 mirid@tlvmc.gov.il

Locations
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Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Idit Matot, Prof    972-3-6974758 ext 4758    iditm@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Idit Matot, MD, PhD Tel-Aviv Sourasky Medical Center

Publications:

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03498898    
Other Study ID Numbers: TASMC-17-IM-0598-CTIL
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tel-Aviv Sourasky Medical Center:
Beta adrenergic receptor blockers
Analgesia nociceptive index
Total hip replacement
Total knee replacement
Additional relevant MeSH terms:
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Nociceptive Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Adrenergic beta-Antagonists
Adrenergic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action