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

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ClinicalTrials.gov Identifier: NCT04622904
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, 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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain, Acute Pain, Chronic Pain, Neuropathic Lidocaine Ketamine Magnesium Central Nervous System Depressants Analgesics Neurotransmitter Agents Analgesics, Non-narcotic Drug: lidocaine-magnesium infusion Drug: lidocaine-ketamine infusion Drug: lidocaine infusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 14, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Active Comparator: lidocaine-magnesium group
combination of lidocaine and magnesium infusions
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

Active Comparator: lidocaine-ketamine group
combination of lidocaine and ketamine infusions
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

Active Comparator: lidocaine group
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 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




Primary Outcome Measures :
  1. 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

  2. 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"

  3. 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"

  4. 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"

  5. 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"

  6. 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"

  7. 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"


Secondary Outcome Measures :
  1. Post Anesthesia Care Unit (PACU) duration of stay [ Time Frame: immediately postoperatively ]
    duration of patient stay at PACU

  2. 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

  3. 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

  4. 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

  5. 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

  6. morphine consumption in Post-Anesthesia Care Unit (PACU) [ Time Frame: immediately postoperatively ]
    mg of morphine requested during patient PACU stay

  7. 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

  8. 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)

  9. first mobilization after surgery [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time at which they mobilized after surgery

  10. 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

  11. 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

  12. first fluid intake [ Time Frame: 48 hours postoperatively ]
    patients will be questioned regarding the time they had their first fluid intake

  13. first solid intake [ Time Frame: 48 hours postoperatively ]
    patients will be questioned regarding the time they had their first solid intake

  14. hospitalization time [ Time Frame: 96 hours postoperatively ]
    duration of hospital stay after surgery in days

  15. 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

  16. side effects intraoperatively [ Time Frame: intraoperatively ]
    patients will be monitored for side-effects of the administered agents intraoperatively

  17. side effects postoperatively [ Time Frame: 72 hours postoperatively ]
    patients will be monitored for side-effects of the administered agents postoperatively

  18. 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

  19. 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


Other Outcome Measures:
  1. 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)

  2. time to extubation [ Time Frame: end of operation, approximately 2 hours after start of surgery ]
    time from sevoflurane discontinuation to tracheal extubation



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only female patients are subjected to gynecological suregry
Accepts Healthy Volunteers:   No
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
  • lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622904


Contacts
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Contact: Kassiani Theodoraki, PhD, DESA +306974634162 ktheodoraki@hotmail.com
Contact: Sofia Apostolidou, MD sofia.apos@hotmail.com

Locations
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Greece
Aretaieion University Hospital Recruiting
Athens, Greece, 115 28
Contact: Kassiani Theodoraki, PhD, DESA    #306974634162    ktheodoraki@hotmail.com   
Sponsors and Collaborators
Aretaieion University Hospital
Investigators
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Principal Investigator: Kassiani Theodoraki, PhD, DESA Aretaieion University Hospital
Publications:

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Responsible Party: Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT04622904    
Other Study ID Numbers: 11/2020
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Pain, Postoperative
Acute Pain
Chronic Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents