The Impact of Esmolol Administration on Postoperative Recovery

Not Applicable

Recruiting

• Conditions: Pain, Acute; Pain, Postoperative; Pain, Chronic Post-Surgical; Esmolol; Nociceptive Pain; Inguinal Hernia Repair; Analgesia
• Interventions: Drug: Esmolol Hydrochloride; Drug: normal saline

• Registration Number: NCT05567822
• Lead Sponsor: Aretaieion University Hospital

Brief Summary

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

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

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted: 2022-10-01
• Study First Submitted QC: 2022-10-01
• Study First Posted: 2022-10-05
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
esmolol group	Esmolol Hydrochloride	loading dose of esmolol 0.05 mL/kg and maintenance dose of esmolol 0.3 mL/kg/h
placebo group	normal saline	loading dose of 0.9% sodium chloride 0.05 mL/kg and maintenance dose of 0.9% sodium chloride 0.3 mL/kg/h

Primary Outcome Measures

Name	Time	Method
pain score 24 hours postoperatively	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"
pain score 3 hours postoperatively	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"
pain score 6 hours postoperatively	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"

Trial Locations

Locations (1)

Evangelismos General Hospital; 🇬🇷 Athens, Greece