The Impact of Esmolol Administration on Postoperative Recovery

Pain, Postoperative Clinical Trial

— esmolol  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567822
• Other study ID #: 89/24-03-2022
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2022
• Source: Aretaieion University Hospital
• Contact: Kassiani Theodoraki, PhD, DESA
• Phone: +306974634162
• Email: ktheodoraki[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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
• ß-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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Chronic Pain
• Hernia, Inguinal
• Inguinal Hernia Repair
• Nociceptive Pain
• Pain, Acute
• Pain, Postoperative

Intervention

Drug:
• Esmolol Hydrochloride
In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively
• normal saline
In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively

Locations

Country	Name	City	State
Greece	Evangelismos General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. Review. — View 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. Review. — View 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. Review. — View 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. — View Citation

Salomé 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). pii: 2069. doi: 10.3390/jcm10102069. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pain score on arrival to Post-Anesthesia Care Unit (PACU)	pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	immediately postoperatively
Other	pain score at discharge from Post-Anesthesia Care Unit (PACU)	pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively]
Other	sevoflurane consumption during general anesthesia	the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined	change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
Other	time to first request for analgesia	the time for the first patient request for analgesia will be noted	during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Other	morphine consumption in Post-Anesthesia Care Unit (PACU)	mg of morphine requested during patient PACU stay	immediately postoperatively
Other	tramadol consumption in the first 24 hours	patients will be followed for cumulative tramadol consumption for 24 hours postoperatively	24 hours postoperatively
Other	fentanyl requirement during surgery	dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value	intraoperatively
Other	time to emergence	time from sevoflurane discontinuation to first patient response (eye opening)	up to 2 hours after start of surgery
Other	time to extubation	time from sevoflurane discontinuation to tracheal extubation	up to 2 hours after start of surgery
Other	Post Anesthesia Care Unit (PACU) duration of stay	duration of patient stay at PACU	immediately postoperatively
Other	sedation on arrival to Post-Anesthesia Care Unit	sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain	immediately postoperatively
Other	sedation at discharge from Post-Anesthesia Care (PACU) Unit	sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain	at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Other	side effects postoperatively	patients will be monitored for side-effects of the administered agents postoperatively	48 hours postoperatively
Other	satisfaction from analgesia	satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction	at discharge from Post Anesthesia Care Unit, approximately 1 hour postoperatively
Other	change from baseline in Quality of Recovery (QoR)-15 score after surgery	The QoR-15 is a quality of recovery scale that consists of 15 questions (items),including questions regarding pain (2 items), physical comfort (5 items), self-care ability (2 items), psychological support (2 items) and emotional state (4 items). Every item is scored on a scale of 10, with the lowest total score of 0 and the highest score of 150. The higher the score, the better the recovery quality of the patient	24 hours postoperatively
Other	sleep quality	subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality)	24 hours postoperatively
Other	first mobilization after surgery	patients will be questioned regarding the time at which they mobilized after surgery	24 hours postoperatively
Other	gastrointestinal recovery after surgery	patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery	24 hours postoperatively
Other	first fluid intake	patients will be questioned regarding the time they had their first fluid intake	24 hours postoperatively
Other	first solid intake	patients will be questioned regarding the time they had their first solid intake	24 hours postoperatively
Other	hospitalization time	duration of hospital stay after surgery in hours	96 hours postoperatively
Other	incidence of chronic pain 1 month after surgery	occurrence of chronic pain at the site of the operation 1 month after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement	1 month after surgery
Other	incidence of chronic pain 3 months after surgery	occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement	3 months after surgery
Other	duration of nociception level<25 intraoperatively	nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels<25 suggest adequate intraoperatively analgesia	intraoperatively
Other	change from baseline in cortisol levels after surgery	blood samples will be collected to measure the variation in cortisol levels from the induction of anesthesia till the arrival of the patient to the Post Anesthesia CAre Unit	during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Other	change from baseline in prolactin levels after surgery	blood samples will be collected to measure the variation in prolactin levels from the induction of anesthesia till the arrival of the patient to the Post Anesthesia CAre Unit	during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Other	change from baseline in lactate levels after surgery	blood samples will be collected to measure the variation in lactate levels from the induction of anesthesia till the arrival of the patient to the Post Anesthesia CAre Unit	during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively
Primary	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
Primary	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
Primary	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