A Phase 4 interventional study of Lidocaine and Placebo in Pain, Postoperative, sponsored by B.P. Koirala Institute of Health Sciences. Completed at 1 site in Nepal. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by B.P. Koirala Institute of Health Sciences · Phase 4, Interventional, and Treatment
This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →B.P. Koirala Institute of Health Sciences is the lead sponsor of 54 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery
Drug: Lidocaine
They will receive the same volume of 0.9% of normal saline as calculated for the experimental group
Drug: Placebo
Postoperative analgesic effects will be compared between lidocaine and normal saline group
Postoperative anlagesic requirements will be calculated and compared with experimental group
Postoperative Numeric Rating Scale(NRS)
Pain at rest and with cough or movement using the NRS scale, which ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain
Time frame: 24 hours
Total opioid consumption
Total morphine or morphine equivalent in milligram
Time frame: 24 hours
Time to first analgesic request
Time to first analgesic (ketorolac) request (time counted after skin closure)
Time frame: 24 hours
Side effects
Number of patients with light headedness, sedation, nausea, vomiting will be documented
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Dec 2018, 8 months.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 8 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, 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
B.P. Koirala Institute of Health Sciences