Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lidocaine and Magnesium and Ketamine in Gynecological Surgery (annie-sophia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04622904
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Tracking Information
First Submitted Date  ICMJE October 31, 2020
First Posted Date  ICMJE November 10, 2020
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE November 14, 2020
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
  • 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
  • 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"
  • 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 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 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 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"
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • 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
  • 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"
  • 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 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 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: 6 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 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"
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
  • Post Anesthesia Care Unit (PACU) duration of stay [ Time Frame: immediately postoperatively ]
    duration of patient stay at PACU
  • sedation on arrival to Post-Anesthesia Care Unit [ Time Frame: 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
  • sedation at discharge from Post-Anesthesia Care (PACU) Unit [ Time Frame: 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
  • sevoflurane consumption during general anesthesia [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: immediately postoperatively ]
    mg of morphine requested during patient PACU stay
  • morphine consumption in the first 48 hours [ Time Frame: 48 hours postoperatively ]
    patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
  • sleep quality [ Time Frame: 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 mobilization after surgery [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time at which they mobilized after surgery
  • gastrointestinal recovery after surgery [ Time Frame: 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
  • satisfaction from postoperative analgesia [ Time Frame: 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 [ Time Frame: 48 hours postoperatively ]
    patients will be questioned regarding the time they had their first fluid intake
  • first solid intake [ Time Frame: 48 hours postoperatively ]
    patients will be questioned regarding the time they had their first solid intake
  • hospitalization time [ Time Frame: 96 hours postoperatively ]
    duration of hospital stay after surgery in days
  • fentanyl requirement during surgery [ Time Frame: intraoperatively ]
    dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
  • side effects intraoperatively [ Time Frame: intraoperatively ]
    patients will be monitored for side-effects of the administered agents intraoperatively
  • side effects postoperatively [ Time Frame: 72 hours postoperatively ]
    patients will be monitored for side-effects of the administered agents postoperatively
  • incidence of chronic pain 1 month after surgery [ Time Frame: 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
  • incidence of chronic pain 3 months after surgery [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • Post Anesthesia Care Unit (PACU) duration of stay [ Time Frame: immediately postoperatively ]
    duration of patient stay at PACU
  • sedation on arrival to Post-Anesthesia Care Unit [ Time Frame: 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
  • sedation at discharge from Post-Anesthesia Care (PACU) Unit [ Time Frame: at discharge from PACU, approximately 1 h 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: immediately postoperatively ]
    mg of morphine requested during patient PACU stay
  • morphine consumption in the first 48 hours [ Time Frame: 48 hours postoperatively ]
    patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
  • sleep quality [ Time Frame: 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 mobilization after surgery [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time at which they mobilized after surgery
  • gastrointestinal recovery after surgery [ Time Frame: 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
  • satisfaction from postoperative analgesia [ Time Frame: 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 [ Time Frame: 48 hours postoperatively ]
    patients will be questioned regarding the time they had their first fluid intake
  • first solid intake [ Time Frame: 48 hours postoperatively ]
    patients will be questioned regarding the time they had their first solid intake
  • hospitalization time [ Time Frame: 96 hours postoperatively ]
    duration of hospital stay after surgery in days
  • fentanyl requirement during surgery [ Time Frame: intraoperatively ]
    dose of required remifentanil intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
  • side effects intraoperatively [ Time Frame: intraoperatively ]
    patients will be monitored for side-effects of the administered agents intraoperatively
  • side effects postoperatively [ Time Frame: 76 hours postoperatively ]
    patients will be monitored for side-effects of the administered agents postoperatively
  • incidence of chronic pain 1 month after surgery [ Time Frame: 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
  • incidence of chronic pain 3 months after surgery [ Time Frame: 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
Current Other Pre-specified Outcome Measures
 (submitted: November 5, 2020)
  • time to emergence [ Time Frame: end of operation, approximately 2 hours after start of surgery ]
    time from sevoflurane discontinuation to first patient response (eye opening)
  • time to extubation [ Time Frame: end of operation, approximately 2 hours after start of surgery ]
    time from sevoflurane discontinuation to tracheal extubation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Lidocaine and Magnesium and Ketamine in Gynecological Surgery
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain, Postoperative
  • Pain, Acute
  • Pain, Chronic
  • Pain, Neuropathic
  • Lidocaine
  • Ketamine
  • Magnesium
  • Central Nervous System Depressants
  • Analgesics
  • Neurotransmitter Agents
  • Analgesics, Non-narcotic
Intervention  ICMJE
  • Drug: lidocaine-magnesium 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 50 mL syringe and administered at a rate of 20 mL/h
  • Drug: lidocaine-ketamine 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 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 50 mL syringe and administered at a rate of 20 mL/h
  • 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 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
Study Arms  ICMJE
  • Active Comparator: lidocaine-magnesium group
    combination of lidocaine and magnesium infusions
    Intervention: Drug: lidocaine-magnesium infusion
  • Active Comparator: lidocaine-ketamine group
    combination of lidocaine and ketamine infusions
    Intervention: Drug: lidocaine-ketamine infusion
  • Active Comparator: lidocaine group
    lidocaine infusion alone
    Intervention: Drug: lidocaine infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • lack of informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: only female patients are subjected to gynecological suregry
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kassiani Theodoraki, PhD, DESA +306974634162 ktheodoraki@hotmail.com
Contact: Sofia Apostolidou, MD sofia.apos@hotmail.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04622904
Other Study ID Numbers  ICMJE 11/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Kassiani Theodoraki, Aretaieion University Hospital
Study Sponsor  ICMJE Aretaieion University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kassiani Theodoraki, PhD, DESA Aretaieion University Hospital
PRS Account Aretaieion University Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP