The Impact of Esmolol Administration on Postoperative Recovery

Study Overview
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Brief Summary
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The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain

Detailed Description
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Contemporary anaesthesiology requires the quest of ways to restrict the use of opioids, which aim at the alleviation of severe postoperative and chronic pain. This is not only due to the side effects involved but also to the epidemic dimensions their use entails. Esmolol, an extremely short-acting cardioselective antagonist of β1 adrenergic receptors, is effectively used in order to attenuate the stress response and minimize undesirable perioperative hemodynamic changes. More specifically, esmolol has been used effectively to reduce pain during induction of anesthesia with propofol and treat tachycardia and hypertension during laryngoscopy. However, recent studies also highlight a possible antinociceptive and/or analgesic effect of esmolol. Therefore, The aim of this study will be to investigate the effect of a continuous infusion of low dose esmolol on intraoperative and postoperative opioid consumption, as well as on postoperative recovery and chronic pain

Official Title
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The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain

Conditions
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Esmolol, Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical, Inguinal Hernia Repair, Analgesia, Nociceptive Pain

Intervention / Treatment
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* Drug: Esmolol Hydrochloride
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients American Society of Anesthesiologists (ASA) classification I-II elective inguinal hernia repair Exclusion Criteria: body mass index (BMI) >35 kg/m2 β-blocker administration preoperatively systematic use of analgesic agents preoperatively chronic pain syndromes preoperatively neurological or psychiatric disease on treatment pregnancy severe hepatic or renal disease history of cardiovascular diseases/ arrhythmias/ conduction abnormalities hemodynamic instability drug or alcohol abuse language or communication barriers lack of informed consent bilateral inguinal hernia repair

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: esmolol group<br>loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h | Drug: Esmolol Hydrochloride<br>* In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively<br>|
| Placebo Comparator: placebo group<br>loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h | Drug: normal saline<br>* In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score 3 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 3 hours postoperatively | 
| pain score 6 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 6 hours postoperatively | 
| pain score 24 hours postoperatively | pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means no pain and 10 means worst pain imaginable | 24 hours postoperatively |