Clinical trial NCT05567822: The Impact of Esmolol Administration on Postoperative Recovery
Official title: The Effect of Intraoperative Esmolol Administration on Postoperative Recovery and Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Pain, Postoperative
Pain, Chronic Post-Surgical
Esmolol
Inguinal Hernia Repair
Analgesia
Nociceptive Pain
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: pain score 3 hours postoperatively
timeFrame: 3 hours postoperatively
measure: pain score 6 hours postoperatively
timeFrame: 6 hours postoperatively
measure: pain score 24 hours postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
measure: pain score on arrival to Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: pain score at discharge from Post-Anesthesia Care Unit (PACU)
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
measure: sevoflurane consumption during general anesthesia
timeFrame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
measure: time to first request for analgesia
timeFrame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: morphine consumption in Post-Anesthesia Care Unit (PACU)
timeFrame: immediately postoperatively
measure: tramadol consumption in the first 24 hours
timeFrame: 24 hours postoperatively
measure: fentanyl requirement during surgery
timeFrame: intraoperatively
measure: time to emergence
timeFrame: up to 2 hours after start of surgery
measure: time to extubation
timeFrame: up to 2 hours after start of surgery
measure: Post Anesthesia Care Unit (PACU) duration of stay
timeFrame: immediately postoperatively
measure: sedation on arrival to Post-Anesthesia Care Unit
timeFrame: immediately postoperatively
measure: sedation at discharge from Post-Anesthesia Care (PACU) Unit
timeFrame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
measure: side effects postoperatively
timeFrame: 48 hours postoperatively
measure: satisfaction from analgesia
timeFrame: at discharge from Post Anesthesia Care Unit, approximately 1 hour postoperatively
measure: change from baseline in Quality of Recovery (QoR)-15 score after surgery
timeFrame: 24 hours postoperatively
measure: sleep quality
timeFrame: 24 hours postoperatively
measure: first mobilization after surgery
timeFrame: 24 hours postoperatively
measure: gastrointestinal recovery after surgery
timeFrame: 24 hours postoperatively
measure: first fluid intake
timeFrame: 24 hours postoperatively
measure: first solid intake
timeFrame: 24 hours postoperatively
measure: hospitalization time
timeFrame: 96 hours postoperatively
measure: incidence of chronic pain 1 month after surgery
timeFrame: 1 month after surgery
measure: incidence of chronic pain 3 months after surgery
timeFrame: 3 months after surgery
measure: duration of nociception level<25 intraoperatively
timeFrame: intraoperatively
measure: change from baseline in cortisol levels after surgery
timeFrame: during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
measure: change from baseline in prolactin levels after surgery
timeFrame: during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
measure: change from baseline in lactate levels after surgery
timeFrame: during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Locations:
city: Athens
country: Greece
facility: Evangelismos General Hospital
Study officials:
References:
citation: Egan TD. Are opioids indispensable for general anaesthesia? Br J Anaesth. 2019 Jun;122(6):e127-e135. doi: 10.1016/j.bja.2019.02.018. Epub 2019 Mar 28.
citation: Salome A, Harkouk H, Fletcher D, Martinez V. Opioid-Free Anesthesia Benefit-Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 May 12;10(10):2069. doi: 10.3390/jcm10102069.
citation: Bahr MP, Williams BA. Esmolol, Antinociception, and Its Potential Opioid-Sparing Role in Routine Anesthesia Care. Reg Anesth Pain Med. 2018 Nov;43(8):815-818. doi: 10.1097/AAP.0000000000000873.
citation: Gelineau AM, King MR, Ladha KS, Burns SM, Houle T, Anderson TA. Intraoperative Esmolol as an Adjunct for Perioperative Opioid and Postoperative Pain Reduction: A Systematic Review, Meta-analysis, and Meta-regression. Anesth Analg. 2018 Mar;126(3):1035-1049. doi: 10.1213/ANE.0000000000002469.
citation: Watts R, Thiruvenkatarajan V, Calvert M, Newcombe G, van Wijk RM. The effect of perioperative esmolol on early postoperative pain: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):28-39. doi: 10.4103/0970-9185.202182.
citation: Andresen K, Rosenberg J. Management of chronic pain after hernia repair. J Pain Res. 2018 Apr 5;11:675-681. doi: 10.2147/JPR.S127820. eCollection 2018.