Lidocaine and Magnesium and Ketamine in Gynecological Surgery
- Conditions
- Pain, NeuropathicKetamineCentral Nervous System DepressantsAnalgesicsAnalgesics, Non-narcoticPain, PostoperativePain, AcutePain, ChronicNeurotransmitter AgentsLidocaine
- Interventions
- Registration Number
- NCT04622904
- Lead Sponsor
- Aretaieion University Hospital
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- adult female patients
- American Society of Anesthesiologists (ASA) classification I-II
- elective open gynecological surgery
- 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
- 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 lidocaine-ketamine group lidocaine-ketamine infusion combination of lidocaine and ketamine infusions lidocaine group lidocaine infusion lidocaine infusion alone lidocaine-magnesium group lidocaine-magnesium infusion combination of lidocaine and magnesium infusions
- Primary Outcome Measures
Name Time Method pain score 48 hours postoperatively 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"
pain score at discharge from Post-Anesthesia Care Unit (PACU) at discharge from PACU, approximately 1 h 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"
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"
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
- Secondary Outcome Measures
Name Time Method Post Anesthesia Care Unit (PACU) duration of stay immediately postoperatively duration of patient stay at PACU
morphine consumption in the first 48 hours 48 hours postoperatively patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
side effects postoperatively 72 hours postoperatively patients will be monitored for side-effects of the administered agents postoperatively
first mobilization after surgery 24 hours postoperatively patients will be questioned regarding the time at which they mobilized after surgery
hospitalization time 96 hours postoperatively duration of hospital stay after surgery in days
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
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
sevoflurane consumption during general anesthesia change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 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
time to first request for analgesia during stay in Post-Anesthesia Care Unit, 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
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)
first solid intake 48 hours postoperatively patients will be questioned regarding the time they had their first solid intake
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 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
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 fluid intake 48 hours postoperatively patients will be questioned regarding the time they had their first fluid intake
sedation at discharge from Post-Anesthesia Care (PACU) Unit at discharge from 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
gastrointestinal recovery after surgery 48 hours postoperatively patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus after surgery
Trial Locations
- Locations (1)
Aretaieion University Hospital
🇬🇷Athens, Greece