The Effect of Intravenous Infusions of Lidocaine and Magnesium Versus Lidocaine and Ketamine Versus Lidocaine Alone on Recovery Profile and Postoperative Pain After Elective Gynecological Surgery
Overview
- Phase
- Not Applicable
- Intervention
- lidocaine-magnesium infusion
- Conditions
- Pain, Postoperative
- Sponsor
- Aretaieion University Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- pain score 48 hours postoperatively
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital
Eligibility Criteria
Inclusion Criteria
- •adult female patients
- •American Society of Anesthesiologists (ASA) classification I-II
- •elective open 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
- •drug or alcohol abuse
- •language or communication barriers
Arms & Interventions
lidocaine-magnesium group
combination of lidocaine and magnesium infusions
Intervention: lidocaine-magnesium infusion
lidocaine-ketamine group
combination of lidocaine and ketamine infusions
Intervention: lidocaine-ketamine infusion
lidocaine group
lidocaine infusion alone
Intervention: lidocaine infusion
Outcomes
Primary Outcomes
pain score 48 hours postoperatively
Time Frame: 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 3 hours postoperatively
Time Frame: 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 at discharge from Post-Anesthesia Care Unit (PACU)
Time Frame: 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 6 hours postoperatively
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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 Outcomes
- Post Anesthesia Care Unit (PACU) duration of stay(immediately postoperatively)
- morphine consumption in the first 48 hours(48 hours postoperatively)
- side effects postoperatively(72 hours postoperatively)
- first mobilization after surgery(24 hours postoperatively)
- hospitalization time(96 hours postoperatively)
- incidence of chronic pain 1 month after surgery(1 month after surgery)
- sedation on arrival to Post-Anesthesia Care Unit(immediately postoperatively)
- sevoflurane consumption during general anesthesia(change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours)
- time to first request for analgesia(during stay in Post-Anesthesia Care Unit, approximately 1 hour postoperatively)
- morphine consumption in Post-Anesthesia Care Unit (PACU)(immediately postoperatively)
- sleep quality(24 hours postoperatively)
- first solid intake(48 hours postoperatively)
- fentanyl requirement during surgery(intraoperatively)
- side effects intraoperatively(intraoperatively)
- incidence of chronic pain 3 months after surgery(3 months after surgery)
- satisfaction from postoperative analgesia(24 hours postoperatively)
- first fluid intake(48 hours postoperatively)
- sedation at discharge from Post-Anesthesia Care (PACU) Unit(at discharge from PACU, approximately 1 hour postoperatively)
- gastrointestinal recovery after surgery(48 hours postoperatively)