An interventional study of lidocaine-magnesium infusion and lidocaine-ketamine infusion in Pain, Postoperative, Pain, Acute and Pain, Chronic, sponsored by Aretaieion University Hospital. Status unknown at 1 site in Greece. Open to female participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Aretaieion University Hospital · Not applicable, Interventional, and Prevention
The aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine and magnesium versus a combination of intravenous infusions of lidocaine and ketamine versus an intravenous infusion of lidocaine alone on recovery profile, quality of recovery and postoperative pain after elective gynecological surgery
Inadequately treated postoperative pain after gynecological surgery may untowardly affect early recovery and also lead to the development of chronic 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, magnesium (acting through modification of the action of N-methyl-D-aspartate receptors) is another agent, which, as an adjuvant to general anesthesia may improve postoperative recovery and pain control through inhibition of cardiovascular response, reduction in general anesthetic needs, enhanced analgesia and anti-inflammatory response.
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 of infusions 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 a sole agent alone. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine and magnesium versus a combination of intravenous infusions of lidocaine and ketamine versus an intravenous infusion of lidocaine alone on recovery profile, quality of recovery and postoperative pain after elective gynecological surgery.
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Exclusion Criteria:
combination of lidocaine and magnesium infusions
Drug: lidocaine-magnesium infusion
combination of lidocaine and ketamine infusions
Drug: lidocaine-ketamine infusion
lidocaine infusion alone
Drug: lidocaine infusion
A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of ketamine of 0.35 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 0.2 mg/kg/h of ketamine will be administered intraoperatively diluted in a 60 mL syringe and administered at a rate of 20 mL/h
A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of magnesium of 50 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 10 mg/kg/h of magnesium will be administered intraoperatively diluted in a 60 mL syringe and administered at a rate of 20 mL/h
A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of normal saline 100 mL will be administered preoperatively within 10 minutes. Followingly, normal saline will be administered intraoperatively at a rate of 20 mL/h
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
Time frame: 24 hours postoperatively
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"
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 PACU, approximately 1 h 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
pain score 48 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 48 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
Time frame: 48 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 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 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, approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
mg of morphine requested during patient PACU stay
Time frame: immediately postoperatively
morphine consumption in the first 48 hours
patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
Time frame: 48 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: 48 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: 48 hours postoperatively
first solid intake
patients will be questioned regarding the time they had their first solid intake
Time frame: 48 hours postoperatively
hospitalization time
duration of hospital stay after surgery in days
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: 72 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
time to emergence
time from sevoflurane discontinuation to first patient response (eye opening)
Time frame: end of operation, approximately 2 hours after start of surgery
time to extubation
time from sevoflurane discontinuation to tracheal extubation
Time frame: end of operation, approximately 2 hours after start of surgery
Plan to share: No
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Aretaieion University Hospital