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

NCT07629713 | Completed Phase 4

• 1 other identifier: head holder
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute

Keywords

Pituitary adenoma; Head-holder; Local anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Study Arms (2)

local anesthesia 1

ACTIVE COMPARATOR

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.

local anesthesia 2

ACTIVE COMPARATOR

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.

Interventions

lidocaine was administered subcutaneously at 0.5% concentration. DRUG

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

Also known as: aritmal

local anesthesia 1

lidocaine was administered subcutaneously at 1% concentration. DRUG

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

Also known as: aritmal

local anesthesia 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 2-3

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli Üniversitesi Tıp Fakültesi Hastanesi

Kocaeli, İzmit, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• DİLEK İÇLİ

  PROFESSOR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: June 5, 2026
• Study Start: January 10, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 16, 2020
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Can be shared indefinitely, 2 years after the study is completed
• Access Criteria: head holder , skull-pin, Lidocaine , Transsphenoidal pituitary surgery

Locations

TU (1)