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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498898
Enrollment
120
Registered
2018-04-17
Start date
2018-06-01
Completion date
2019-10-01
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nociceptive Pain

Keywords

Beta adrenergic receptor blockers, Analgesia nociceptive index, Total hip replacement, Total knee replacement

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).

Interventions

OTHERChronic use of Beta adrenergic receptor blocker

Chronic use of Beta adrenergic receptor blocker

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fentanyl consumption during surgery.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

MeasureTime frameDescription
Post operative Morphine consumption.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).
Post operative non opioid analgesia consumption.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.
Post operative pain (NRS score).15 minutes after admission to PACU.Measuring the effect of chronic use of Beta adrenergic receptor blockers on NRS pain score.

Countries

Israel

Contacts

Primary ContactIdit Matot, MD, PhD
iditm@tlvmc.gov.il97236974758
Backup ContactMiri Davidovich
mirid@tlvmc.gov.il97236974758

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026