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Hemodynamic Instabilityscalp blockNCT06264765

Scalp Block -Craniotomi

A study testing scalp block and Incisional infiltration in people with Hemodynamic Instability, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hemodynamic Instability
What is being tested?
scalp block and Incisional infiltration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2024to 1 Jan 2026
Phase
Interventional
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

  • Patients who underwent craniotomy under elective conditions
  • ASA I-III
  • 18-75 years old
  • GCS >13

Who cannot join

  • GCS <13
  • Emergency surgery
  • Presence of contraindications to the LA agents used in this study
  • Chronic use of opioids
  • Psychiatric disorders
  • Presence of infection at the injection site
Show all 11Show fewer
  • Uncontrolled intracranial hypertension
  • Chronic hypertension,
  • Coronary artery disease, arrhythmia,
  • Coagulopathy,
  • Patients who have previously undergone craniotomy

Trial locations and contacts

1 site in 1 country.

ferdi gülaştı contact

5054929650

ferdigulasti@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ferdi Gülaştı

    Aydin, 09020

    Ferdi Gülaştı, ferdigulasti@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison Of The Effect Of Scalp Block And Incision Sıte Infiltratıon Applied On Postoperative Acute Paın And Hemodynamics In Patients Undergoing Craniotomy

Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.

In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended.

Read the detailed description

intraoperative Routine anesthesia induction will be applied after routine monitoring in the operating room. Anesthesia will be induced with propofol (1.5-2 mg/kg), rocuronium (0.6 mg/kg), fentanyl (1mcg/kg), 0.7 FiO2 oxygen. After intubation, general anesthesia will be maintained with the effect site model of target control infusion with propofol and remifentanil. Target concentrations will be maintained at 2 to 3 µg/ml propofol and 2 to 6 ng/ml remifentanil. The propofol dose was titrated according to the depth of anesthesia. The bispectral index will be kept between 45 and 60. Radial artery and urinary catheter will be inserted.

Group S: Following induction of anesthesia, a scalp block will be performed before the surgery begins.

Group I: Incisional infiltration will be performed before the surgery begins, following induction of anesthesia for the patient.

Scalp block: Scalp block will be performed by the anesthesiologist 10 minutes before the pin head holder application (PHHA). Supraorbital and supratrochlear nerves will be blocked bilaterally with 6 ml of 0.5% bupivacaine injected vertically into the skin above the eyebrow midline. Auriculotemporal nerves will be blocked bilaterally by injecting 4 ml of 0.5% bupivacaine 1.5 cm anterior to the ear at the tragus level. The needle will be inserted perpendicular to the skin and the fascia will be injected deeply and superficially while the needle is withdrawn. Postauricular branches of the greater auricular nerves will be blocked bilaterally with 2 ml of 0.5% bupivacaine injected 1 cm posterior to the ear, between the bone and skin, at the level of the tragus. The greater, lesser, and third occipital nerves will be blocked bilaterally with 8 ml of 0.5% bupivacaine injected along the upper nuchal line, approximately halfway between the occipital protuberance and the mastoid prominence.

Incisional infiltration: 20 ml of 0.5% bupivacaine will be infiltrated by the surgeon into the PHHA points and surgical incision areas 10 minutes before PHHA. If the mean arterial pressure (MAP) and heart rate increase above 20% of the baseline values in both groups, additional remifentanil 50 µg IV will be administered.

Intraoperative analgesia will be provided only with remifentanil. Sugammadex (2 mg/kg will be used to reverse the remaining muscle relaxation at the end of the surgery). Ondansetron (8 mg IV) will be administered as antiemetic prophylaxis. All patients will be extubated at the end of the surgery and will be admitted to the neurosurgery intensive care unit for 24 hours postoperatively.

Postoperative The per-operative analgesia plan will be applied the same to all patients. In this protocol, intravenous paracetamol 1 g. and tramadol was determined as 1mg/kg. Then it is paracetamol every eight hours and tramadol from PCA.

At the end of the operation, patients' pain levels will be determined and recorded using the Numeric Rating Scale (NRS) system at intervals in the first 24 hours postoperatively. NRS; It is a pain intensity determination system based on the system of having the person say a point between 0 (no pain), 10 (unbearable pain) and 10 (unbearable pain) to describe his/her pain. During service follow-ups, if NRS is 4 or above, 75 mg diclofenac sodium will be administered intramuscularly. Analgesia consumption amount, rescue analgesic needs and hours will be noted in detail, and rescue analgesic use as well as NRS scores at specified hours will be evaluated statistically. The postoperative analgesia plan will be applied the same to all patients. This protocol is our routine analgesia protocol that we apply in our hospital for cranial surgeries.

Being tested
scalp block, Incisional infiltration
Keywords
scalp block, opioid consumption, postoperative pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • scalp blockOther

    The scalp block will be performed by the anesthesiologist 10 minutes before the pin head holder application (PHHA). Supraorbital and supratrochlear nerves will be blocked bilaterally with 6 ml of 0.5% bupivacaine injected vertically into the skin above the eyebrow midline. Auriculotemporal nerves will be blocked bilaterally by injecting 4 ml of 0.5% bupivacaine 1.5 cm anterior to the ear at the tragus level. The needle will be inserted perpendicular to the skin and the fascia will be injected deeply and superficially while the needle is withdrawn. Postauricular branches of the greater auricular nerves will be blocked bilaterally with 2 ml of 0.5% bupivacaine injected 1 cm posterior to the ear, between the bone and skin, at the level of the tragus. The greater, lesser, and third occipital nerves run along the upper nuchal line approximately halfway between the occipital prominence and the mastoid prominence.

  • Incisional infiltrationOther

    Incisional infiltration: 20 ml of 0.5% bupivacaine will be infiltrated by the surgeon into the PHHA points and surgical incision areas 10 minutes before PHHA. Two

Study groups in NCT06264765
Study groupRoleWhat they receive
scalp blockOtherFollowing induction of anesthesia, a scalp block will be performed before the surgery begins.
Receives: Other: scalp block
incisional infiltrationOtherFollowing induction of anesthesia, incisional infiltration will be performed before the surgery begins.
Receives: Other: Incisional infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. opioid consumption

    Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.

    Measured: 24 hours

Secondary outcomes (1)
  1. The Numeric Rating Scale (NRS)

    Preoperative period and Postoperative 30th minute, 1st, 6th, 12th, 18th. And at the 24th hour, patients' pain levels and NRS scores will be recorded. At the end of the operation, patients' pain levels will be determined and recorded using the Numeric Rating Scale (NRS) system at intervals in the first 24 hours postoperatively. NRS; It is a pain intensity determination system based on the system of having the person say a point between 0 (no pain), 10 (unbearable pain) and 10 (unbearable pain) to describe his/her pain.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 Jan 2024
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
randomized double blinding
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06264765
Sponsor's protocol ID
22-12-23
Acronym
scalp block
Status last verified
Feb 2024
First submitted
22 Dec 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing scalp block and Incisional infiltration in people with Hemodynamic Instability, run by Aydin Adnan Menderes 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ferdi gülaştı (5054929650, ferdigulasti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

opioid consumption (time frame: 24 hours). 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 20 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.

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