Opioid-free Anesthesia in Laparoscopic Cholecystectomies
- Conditions
- Pain, PostoperativePain, AcuteLidocaineAnalgesiaAnalgesicsKetamineDexmedetomidinePain, ChronicCholecystectomyCentral Nervous System Depressants
- Interventions
- Drug: ketamine-lidocaine-dexmedetomidine
- Registration Number
- NCT05089526
- Lead Sponsor
- Aretaieion University Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- adult patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective laparoscopic cholecystectomy
- body mass index (BMI) >35 kg/m2
- contraindications to local anesthetic administration or non-steroidal agents administration
- 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
- bradycardia(<55 beats/minute)
- drug or alcohol abuse
- language or communication barriers lack of informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketamine-lidocaine-dexmedetomidine (KLD) group ketamine-lidocaine-dexmedetomidine combination of ketamine-lidocaine-dexmedetomidine in one syringe fentanyl (control) group fentanyl syringe of fentanyl
- Primary Outcome Measures
Name Time Method 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"
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"
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"
- Secondary Outcome Measures
Name Time Method first mobilization after surgery 24 hours postoperatively patients will be questioned regarding the time at which they mobilized after surgery
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
tramadol consumption in the first 24 hours 24 hours postoperatively patients will be followed for cumulative tramadol consumption for 24 hours postoperatively
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
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
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
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
satisfaction from postoperative analgesia 24 hours postoperatively satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
first solid intake 24 hours postoperatively patients will be questioned regarding the time they had their first solid intake
side effects intraoperatively intraoperatively patients will be monitored for side-effects of the administered agents intraoperatively
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
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
hospitalization time 96 hours postoperatively duration of hospital stay after surgery in hours
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
side effects postoperatively 48 hours postoperatively patients will be monitored for side-effects of the administered agents postoperatively
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
Trial Locations
- Locations (1)
Evangelismos General Hospital
🇬🇷Athens, Greece