Scalp Block -Craniotomi

Hemodynamic Instability Clinical Trial

— scalp block  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264765
• Other study ID #: 22-12-23
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Aydin Adnan Menderes University
• Contact: ferdi gülasti
• Phone: 5054929650
• Email: ferdigulasti[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients who underwent craniotomy under elective conditions

2. ASA I-III

3. 18-75 years old

4. GCS >13

Exclusion Criteria:

1. GCS <13

2. Emergency surgery

3. Presence of contraindications to the LA agents used in this study

4. Chronic use of opioids

5. Psychiatric disorders

6. Presence of infection at the injection site

7. Uncontrolled intracranial hypertension

8. Chronic hypertension,

9. Coronary artery disease, arrhythmia,

10. Coagulopathy,

11. Patients who have previously undergone craniotomy

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Other:
• scalp block
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 infiltration
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

Locations

Country	Name	City	State
Turkey	Ferdi Gülasti	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption	Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.	24 hours
Secondary	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.	24 hours