The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic cholecystectomies
Inadequately treated postoperative pain after laparoscopic cholecystectomy may untowardly affect early recovery and also lead to the development of chronic pain. Laparoscopic surgery is associated with diminished postoperative pain but this does not mean that patients subjected to laparoscopic operations are not in need for analgesia intra- and postoperatively. Pneumoperitoneum can lead to postoperative discomfort and occasionally intense postoperative shoulder pain. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia. Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay. In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, dexmedetomidine is a highly selective alfa-2 adreno-ceptor agonist that provides sedation, analgesia, and sympatholysis. Its perioperative intravenous administration has been associated with a reduction in postoperative pain intensity, analgesic consumption and nausea. There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations can be used towards the achievement of a completely opioid-free anesthetic regimen. Additionally, it can be hypothesized that the combination of non-opioid drugs with different targets can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of opioids. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine-ketamine-dexmedetomidine versus fentanyl on recovery profile and postoperative pain after elective laparoscopic cholecystectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
70
In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution.
In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.
Evangelismos General Hospital
Athens, Greece
RECRUITINGpain 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"
Time frame: immediately postoperatively
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"
Time frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
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"
Time frame: 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"
Time frame: 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"
Time frame: 24 hours postoperatively
Post Anesthesia Care Unit (PACU) duration of stay
duration of patient stay at PACU
Time frame: immediately postoperatively
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
Time frame: immediately postoperatively
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
Time frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
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
Time frame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours
time to first request for analgesia
the time for the first patient request for analgesia will be noted
Time frame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
mg of morphine requested during patient PACU stay
Time frame: immediately postoperatively
tramadol consumption in the first 24 hours
patients will be followed for cumulative tramadol consumption for 24 hours postoperatively
Time frame: 24 hours postoperatively
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
Time frame: 24 hours postoperatively
first mobilization after surgery
patients will be questioned regarding the time at which they mobilized after surgery
Time frame: 24 hours postoperatively
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
Time frame: 24 hours postoperatively
satisfaction from postoperative analgesia
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
Time frame: 24 hours postoperatively
first fluid intake
patients will be questioned regarding the time they had their first fluid intake
Time frame: 24 hours postoperatively
first solid intake
patients will be questioned regarding the time they had their first solid intake
Time frame: 24 hours postoperatively
hospitalization time
duration of hospital stay after surgery in hours
Time frame: 96 hours postoperatively
fentanyl requirement during surgery
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time frame: intraoperatively
side effects intraoperatively
patients will be monitored for side-effects of the administered agents intraoperatively
Time frame: intraoperatively
side effects postoperatively
patients will be monitored for side-effects of the administered agents postoperatively
Time frame: 48 hours postoperatively
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
Time frame: 1 month after surgery
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
Time frame: 3 months after surgery
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