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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07629713

Enrollment

Registered

2026-06-05

Start date

2018-01-10

Completion date

2020-01-16

Last updated

2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Acute

Keywords

Pituitary adenoma, Head-holder, Local anesthesia

Brief summary

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.

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.

Interventions

DRUGlidocaine was administered subcutaneously at 0.5% concentration.

In Group 1, lidocaine was administered subcutaneously at 0.5% concentration.

DRUGlidocaine was administered subcutaneously at 1% concentration.

In Group 2, lidocaine was administered subcutaneously at 1% concentration.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* ASA 2-3

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORDİLEK İÇLİ

PROFESSOR

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026