Postoperative Pain, AcutePhase 4NCT07629713
The Effect of Local Anesthesia on Postopanalgesia in Patients Using Head Holder
A Phase 4 study testing lidocaine was administered subcutaneously at 0.5% concentration. and lidocaine was administered subcutaneously at 1% concentration. in people with Postoperative Pain, Acute, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- lidocaine was administered subcutaneously at 0.5% concentration. and lidocaine was administered subcutaneously at 1% concentration.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 16 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 2-3
Who cannot join
- ASA 4,
- going to the intensive care unit in the postoperative period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Üniversitesi Tıp Fakültesi Hastanesi
Kocaeli, İzmit, 41100
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- lidocaine was administered subcutaneously at 0.5% concentration., lidocaine was administered subcutaneously at 1% concentration.
- Keywords
- Pituitary adenoma, Head-holder, Local anesthesia
- Medical subject headings
- Pain, Postoperative, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine was administered subcutaneously at 0.5% concentration.Drug
Also called aritmal
In Group 1, lidocaine was administered subcutaneously at 0.5% concentration.
lidocaine was administered subcutaneously at 1% concentration.Drug
Also called aritmal
In Group 2, lidocaine was administered subcutaneously at 1% concentration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: lidocaine was administered subcutaneously at 1% concentration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start10 Jan 2018
- Primary completion15 Jan 2019
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huri Yeşildal, Kocaeli University
- Investigators
- DİLEK İÇLİ, Study director, PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629713
- Sponsor's protocol ID
- head holder
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2 years after the study was completed
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lidocaine Injection at Different Concentrations on Postoperative Pain in Patients Using Head Holder.
- ClinicalTrials.gov ID
- NCT07629713
- Acronym / sponsor ID
- head holder
- Conditions
- Postoperative Pain, Acute
- Keywords
- Pituitary adenoma, Head-holder, Local anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anesthesia 1 | Active comparator | Drug: lidocaine was administered subcutaneously at 0.5% concentration.Lidocaine 0.5% was administered subcutaneously at a concentration of 3 ml at each of the three points, a total of 9 ml. |
| local anesthesia 2 | Active comparator | Drug: lidocaine was administered subcutaneously at 1% concentration.Lidocaine 1% was administered subcutaneously at a concentration of 3 ml at each of the three points, a total of 9 ml. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 2-3
Key exclusion criteria (2 listed)
- ASA 4,
- going to the intensive care unit in the postoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine was administered subcutaneously at 0.5% concentration.Also: aritmalIn Group 1, lidocaine was administered subcutaneously at 0.5% concentration. | Drug | local anesthesia 1 |
| lidocaine was administered subcutaneously at 1% concentration.Also: aritmalIn Group 2, lidocaine was administered subcutaneously at 1% concentration. | Drug | local anesthesia 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. 2 years after the study was completed
Related trials for Postoperative Pain, Acute
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
Postoperative Pain, Acute, Shoulder Pain
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİLEK İÇLİ study director
PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine was administered subcutaneously at 0.5% concentration. and lidocaine was administered subcutaneously at 1% concentration. in people with Postoperative Pain, Acute, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.