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

Primary Purpose

Nociceptive Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Chronic use of Beta adrenergic receptor blocker
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nociceptive Pain focused on measuring Beta adrenergic receptor blockers, Analgesia nociceptive index, Total hip replacement, Total knee replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Group A

Group B

Group C

Group D

Arm Description

American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement

American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement

American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement.

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

Outcomes

Primary Outcome Measures

Fentanyl consumption during surgery.
Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Fentanyl).

Secondary Outcome Measures

Post operative Morphine consumption.
Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Morphine).
Post operative non opioid analgesia consumption.
Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of non opioid analgesia.
Post operative pain (NRS score).
Measuring the effect of chronic use of Beta adrenergic receptor blockers on NRS pain score.

Full Information

First Posted
April 8, 2018
Last Updated
August 14, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03498898
Brief Title
The Effect of Ongoing Beta-blockers Administration on Analgesic Requirements in the Immediate Perioperative Period.
Official Title
The Effect of Ongoing Beta-blockers Administration on Analgesic Requirements in the Immediate Perioperative Period.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain
Keywords
Beta adrenergic receptor blockers, Analgesia nociceptive index, Total hip replacement, Total knee replacement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement
Arm Title
Group B
Arm Type
No Intervention
Arm Description
American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total hip replacement
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
American Society of Anesthesiologists (ASA) Score 2-3 with chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement.
Arm Title
Group D
Arm Type
No Intervention
Arm Description
American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement
Intervention Type
Other
Intervention Name(s)
Chronic use of Beta adrenergic receptor blocker
Intervention Description
Chronic use of Beta adrenergic receptor blocker
Primary Outcome Measure Information:
Title
Fentanyl consumption during surgery.
Description
Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Fentanyl).
Time Frame
Intra operative (anaesthesia start until anaesthesia end).
Secondary Outcome Measure Information:
Title
Post operative Morphine consumption.
Description
Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of analgesia (Morphine).
Time Frame
Immediate post operative time (from admission to release from PACU).
Title
Post operative non opioid analgesia consumption.
Description
Measuring the effect of chronic use of Beta adrenergic receptor blockers on the amount of non opioid analgesia.
Time Frame
Immediate post operative time (from admission to release from PACU).
Title
Post operative pain (NRS score).
Description
Measuring the effect of chronic use of Beta adrenergic receptor blockers on NRS pain score.
Time Frame
15 minutes after admission to PACU.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idit Matot, MD, PhD
Phone
97236974758
Email
iditm@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Miri Davidovich
Phone
97236974758
Email
mirid@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idit Matot, MD, PhD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idit Matot, Prof
Phone
972-3-6974758
Ext
4758
Email
iditm@tasmc.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28132576
Citation
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Results Reference
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Citation
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Citation
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Citation
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The Effect of Ongoing Beta-blockers Administration on Analgesic Requirements in the Immediate Perioperative Period.

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