A Phase 4 interventional study of Lidocaine Hydrochloride and Lidocaine Hydrochloride and Ketamine in Analgesic Drug Dependence, sponsored by Rajmonda Nallbani-Komoni. Status unknown at 2 sites in Kosovo. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by Rajmonda Nallbani-Komoni · Phase 4, Interventional, and Treatment
Postoperative pain continues to be untreated despite the application of multimodal analgesia, medication and new analgesic techniques. Traditional opioid pain treatment has many side effects, while invasive methods, such as epidural catheter, have high costs and difficulties during application.
Lidocaine is a local anesthetic and its administration with intravenous routes has analgesic, antihyperalgic and antiinflammatory action. It increases the motility of the intestine and has antiemetic properties. The advantage of this method is the low cost of the preparation and its easy application. The intravenous administration of lidocaine for postoperative analgesia is recently used and not sufficiently researched technique .
The purpose of this research is to investigate the analgesic effects of intravenous lidocaine in the perioperative and postoperative period, on various surgical interventions. In the perioperative period, its effect on the reduction of opiodic use will be evaluated, while during the postoperative period will be evaluate the degree of analgesia, the rate of reduction of additional analgesics, the impact on the clinical parameters and the patient's rehabilitation.
The research will be conducted at the Clinic of Gynecology and Obstetrics, the Surgery Clinic, the Urology Clinic, the Orthopedic Clinic, of Universitary Clinical Centre of Kosovo and the American Hospital in Pristina, Republic of Kosovo.
The study will be conducted during the period April 2018 - January 2020.
After obtaining a permit from the ethics committee, all patients to be investigated will be informed first through the information form for all the risks and advantages of this analgesic technique and from them will be consented to their participation in the research.
In the intervention group of the study will be included 520 patients of both genders and ages 18-65 years. Patients will undergo these surgical interventions: gynecological, abdominal, laparoscopical, urological and orthopedic interventions.
The intervention group includes two groups for each type of surgery:
Group I (n = 50); at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
Group II (n = 50); at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation.
The control group (n = 30) will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
This is the only study on the registry with Rajmonda Nallbani-Komoni as lead sponsor.
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at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
Drug: Lidocaine Hydrochloride
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
Drug: Lidocaine Hydrochloride · Drug: Lidocaine Hydrochloride and Ketamine
will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
Drug: Placebo
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
Also known as: Lidocaine Hydrochloride ampule
Drug pages: Lidocaine · Ketamine
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
Also known as: Lidocaine Hydrochloride ampule and Ketamine ampule
will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
Also known as: Placebo for(lidocaine hydrochloride)
Reduction of opiods used during perioperative period and other analgesics used during postoperative period
The primary outcome measures are: the use of opiods and other analgesics during and 48 hours after the surgical intervention. During the intraoperative period, it will be investigated how the application of intravenous lidocaine will reduce the amount of opiodes used, amd during the postoperative period will be investigated when the application of other analgesics will start and which analgesics will be used as well,how often they will be given and in which dose. The analgesics which will be investigated include routine analgesics found in our hospital: * tramadol * acetaminophen * diclophenac * ketorolac * others
Time frame: 48 hours after surgical intervention
Pain scores measured at rest and during the movement with Visual Analog Scale
* Pain scores measured at rest and during the movement with Visual Analog Scale * the beginning of the intestinal motility, * side effects (nausea, vomiting, headache, hypotension, arrhythmias, dizziness ,hallucinations etc) Postoperative analgesia will be determined through the VAS scale-Visual Analog Scale. This scale will be used to determinate the intensity of pain in patients in the postoperative period, initially determining the intensity of pain in silence as well as after mobilization or motion, i.e Visual Dynamic Scale. This scale determines the intensity of the pain and is expressed in a numeric value from1-10. 0- no pain, 1-2- mild pain, 3-6 moderate pain, 7-10 severe pain.
Time frame: 48 hours after surgical intervention
Plan to share: Yes — Individual participant data for primary and secondary outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available within 6 months of study completion
Access criteria: Requestors will be required to sign a Data Access Agreement and then these requests will be reviewed by an Independent Review Panel.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Agnosia