The Effect of Local Anesthesia on Postopanalgesia in Patients Using Head Holder

June 1, 2026 updated by: Huri Yeşildal, Kocaeli University

The Effect of Lidocaine Injection at Different Concentrations on Postoperative Pain in Patients Using Head Holder.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmit
      • Kocaeli, İzmit, Turkey (Türkiye), 41100
        • Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA 2-3

Exclusion Criteria:

  • ASA 4,
  • going to the intensive care unit in the postoperative period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: local anesthesia 1
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.
In Group 1, lidocaine was administered subcutaneously at 0.5% concentration.
Other Names:
  • aritmal
Active Comparator: local anesthesia 2
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 2, lidocaine was administered subcutaneously at 1% concentration.
Other Names:
  • aritmal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The aim of this study is to compare postoperative pain levels between two groups of neurosurgery patients who underwent surgery using a head holder.
Time Frame: 5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Study Director: DİLEK İÇLİ, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 16, 2020

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • head holder

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

2 years after the study was completed

IPD Sharing Time Frame

Can be shared indefinitely, 2 years after the study is completed

IPD Sharing Access Criteria

head holder , skull-pin, Lidocaine , Transsphenoidal pituitary surgery

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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