Pain, Acute, Pain, Postoperative, Pain, Chronic Post-Surgical, Esmolol, Inguinal Hernia Repair, Analgesia, Nociceptive Pain
Conditions
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
Interventions
In the esmolol group, patients will receive a bolus dose of esmolol followed by a continuous infusion of esmolol intraoperatively
DRUGnormal saline
In the placebo group, patients will receive a bolus dose of normal saline followed by a continuous infusion of normal saline intraoperatively
Sponsors
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| time to first request for analgesia | during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively | the time for the first patient request for analgesia will be noted |
| morphine consumption in Post-Anesthesia Care Unit (PACU) | immediately postoperatively | mg of morphine requested during patient PACU stay |
| tramadol consumption in the first 24 hours | 24 hours postoperatively | patients will be followed for cumulative tramadol consumption for 24 hours postoperatively |
| fentanyl requirement during surgery | intraoperatively | dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value |
| time to emergence | up to 2 hours after start of surgery | time from sevoflurane discontinuation to first patient response (eye opening) |
| time to extubation | up to 2 hours after start of surgery | time from sevoflurane discontinuation to tracheal extubation |
| Post Anesthesia Care Unit (PACU) duration of stay | immediately postoperatively | duration of patient stay at PACU |
| sedation on arrival to Post-Anesthesia Care Unit | immediately postoperatively | 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 |
| sedation at discharge from Post-Anesthesia Care (PACU) Unit | at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively | 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 |
| side effects postoperatively | 48 hours postoperatively | patients will be monitored for side-effects of the administered agents postoperatively |
| satisfaction from analgesia | at discharge from Post Anesthesia Care Unit, approximately 1 hour postoperatively | satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction |
| change from baseline in Quality of Recovery (QoR)-15 score after surgery | 24 hours postoperatively | 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 |
| pain score on arrival to Post-Anesthesia Care Unit (PACU) | immediately postoperatively | 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 |
| first mobilization after surgery | 24 hours postoperatively | patients will be questioned regarding the time at which they mobilized after surgery |
| gastrointestinal recovery after surgery | 24 hours postoperatively | patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery |
| first fluid intake | 24 hours postoperatively | patients will be questioned regarding the time they had their first fluid intake |
| first solid intake | 24 hours postoperatively | patients will be questioned regarding the time they had their first solid intake |
| hospitalization time | 96 hours postoperatively | duration of hospital stay after surgery in hours |
| incidence of chronic pain 1 month after surgery | 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 |
| incidence of chronic pain 3 months after surgery | 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 |
| duration of nociception level<25 intraoperatively | intraoperatively | nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels\<25 suggest adequate intraoperatively analgesia |
| change from baseline in cortisol levels after surgery | during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively | 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 |
| change from baseline in prolactin levels after surgery | during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively | 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 |
| change from baseline in lactate levels after surgery | during patient stay in the Post Anesthesia Care Unit, approximately 2 hours postoperatively | 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 |
| sleep quality | 24 hours postoperatively | 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) |
| pain score at discharge from Post-Anesthesia Care Unit (PACU) | at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively] | 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 |
| sevoflurane consumption during general anesthesia | change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours | the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined |
Countries
Greece
Contacts
Primary ContactKassiani Theodoraki, PhD, DESA
Backup ContactVasiliki Samartzi
Outcome results
None listed