Clinical trial NCT04858711: Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine
Official title: The Effect of a Mixture of Dexmedetomidine-lidocaine-ketamine in One Syringe Versus Opioids on Recovery Profile and Postoperative Pain After Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Pain, Acute
Pain, Chronic
Pain, Neuropathic
Pain, Nociceptive
Ketamine
Dexmedetomidine
Lidocaine
Central Nervous System Depressants
Analgesia
Analgesics
Analgesics Non-narcotic
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
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 an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic gynecological surgery

Detailed description: Inadequately treated postoperative pain after gynecological surgery 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. 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, quality of recovery and postoperative pain after elective laparoscopic gynecological surgery.

Eligibility criteria: Inclusion Criteria:

* adult female patients
* American Society of Anesthesiologists (ASA) classification I-II
* elective laparoscopic gynecological surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: change from baseline in Quality of Recovery (QoR)-15 score after surgery
timeFrame: 24 hours postoperatively
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: 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:
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: sevoflurane consumption during general anesthesia
timeFrame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2-3 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 48 hours
timeFrame: 48 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: satisfaction from postoperative analgesia
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: fentanyl requirement during surgery
timeFrame: intraoperatively
measure: side effects intraoperatively
timeFrame: intraoperatively
measure: side effects postoperatively
timeFrame: 48 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
Other outcomes:
measure: time to emergence
timeFrame: up to 2-3 hours after start of surgery
measure: time to extubation
timeFrame: up to 2-3 hours after start of surgery
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, phD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
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