An interventional study of Chronic use of Beta adrenergic receptor blocker in Nociceptive Pain, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-16.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Other
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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.
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).
96 studies on the registry are indexed under Nociceptive Pain; 18 are open to participants now.
This study's planned enrollment of 120 is above the median of 61 across 62 interventional studies indexed under Nociceptive Pain.
Browse Nociceptive Pain studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Other: Chronic use of Beta adrenergic receptor blocker
American Society of Anesthesiologists (ASA) Score 2-3 with no chronic use of Beta adrenergic receptor blockers planned to undergo total knee replacement
Chronic use of Beta adrenergic receptor blocker
Fentanyl consumption during surgery.
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).
Post operative Morphine consumption.
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).
Post operative non opioid analgesia consumption.
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).
Post operative pain (NRS score).
Measuring the effect of chronic use of Beta adrenergic receptor blockers on NRS pain score.
Time frame: 15 minutes after admission to PACU.
Plan to share: No
Started Jun 2018 (actual). Primary completion is estimated for Oct 2019, 16 months after the start.
Of 37 non-industry interventional studies with no phase under Nociceptive Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 32. This study's planned 16 months is above that.
Counting every sponsor, half of 42 studies reached it within 8 months; a quarter within 3 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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