A Phase 4 interventional study of lidocaine was administered subcutaneously at 0.5% concentration. and lidocaine was administered subcutaneously at 1% concentration. in Postoperative Pain, Acute, sponsored by Kocaeli University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Kocaeli University · Phase 4, Interventional, and Prevention
Aim:The head holder used in neurosurgery operations causes pain in patients both peroperatively and postoperatively.Severe pain-related hemodynamic changes are seen in these participants.In our study, the investigators compared the effects of two different concentrations of lidocaine on the perioperative and postoperative hemodynamic response caused by the application of the head-holder, and the pain observed in the postoperative period.
Method: Ethics committee approval and participants consent were obtained. Lidocaine 0.5% in Group 1 and 1% lidocaine in Group 2 was administered subcutaneously, 3 ml to each three points, in a total of 9 ml. Postoperative analgesic efficacy and tramadol consumption amounts of different concentrations of lidocaine were compared in participants who used a head holder.
1% concentration of lidocaine as skin infiltration before wearing a head-holder.
compared to 0.5% concentration lidocaine application, pain was controlled in the first hour of the postoperative period.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 75 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Lidocaine 0.5% was administered subcutaneously at a concentration of 3 ml at each of the three points, a total of 9 ml.
Drug: lidocaine was administered subcutaneously at 0.5% concentration.
Lidocaine 1% was administered subcutaneously at a concentration of 3 ml at each of the three points, a total of 9 ml.
Drug: lidocaine was administered subcutaneously at 1% concentration.
In Group 1, lidocaine was administered subcutaneously at 0.5% concentration.
Also known as: aritmal
In Group 2, lidocaine was administered subcutaneously at 1% concentration.
Also known as: aritmal
The aim of this study is to compare postoperative pain levels between two groups of neurosurgery patients who underwent surgery using a head holder.
The aim is to alter pain levels of these two operated groups at the first, third, sixth, twelfth, and twenty-fourth hours after surgery. Change from baseline in pain Scores on the Visiual Analog Scale at one day after surgery
Time frame: 5 years
Plan to share: Yes — 2 years after the study was completed
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Kocaeli University