Clinical trial NCT06951230: The Efficacy of Scalp Block in Craniotomy
Official title: The Efficacy of Scalp Block Versus Intravenous Fentanyl in Pain Control Intraoperatively in Craniotomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-operative Pain
Narcotics Consumption
Pain Assessment
Intraoperative Hemodynamic Instability
Keywords: scalp block
pain
craniotomy
Pain control
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to compare the effectiveness and safety of scalp block versus intravenous fentanyl in pain control intraoperatively in craniotomy patients. Most of the previous studies compared the effect of scalp block versus fentanyl or opioids in postoperative pain

Detailed description: The history will be obtained from patient. The patients fasting 8 hours preoperatively will be examined and assessed, especially neurologically, to exclude any neurological deficit that may affect the results. Pre-operative laboratories will be reviewed for all patients as (complete blood picture, renal function tests, liver function tests, and coagulation profile) .

Patients will be assigned randomly by using a computer -generated table of random numbers, placing them in sealed envelopes, into two groups:

* Group A: (n= 10): patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr)
* Group B (control group): (n= 10): patients will receive general anesthesia then receive scalp block In the operating room, the monitor will be connected to track pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and heart rate (HR). A second recording will occur after induction. An IV cannula will be inserted, and an electrocardiogram (ECG) obtained.

Pre-oxygenation with 100% oxygen will last 3 minutes, followed by IV induction with Propofol (2 mg/kg), Atracurium (0.5 mg/kg), and Fentanyl (1 mcg/kg). The patient will be placed on inhaled Isoflurane, and smooth intubation will be performed. Invasive blood pressure monitoring will be set up via the non-dominant radial artery, and a central venous line will be inserted in the internal jugular vein using ultrasound.

A scalp block will be done blindly for group B, while group A will receive Fentanyl (1 mcg/kg/hr) prior to Mayfield placement and skin incision. Throughout the operation, continuous monitoring of Electrocardiogram, Heart rate, invasive blood pressure (IBP), oxygen saturation and urine output will occur.

The scalp block will be performed under aseptic conditions by qualified personnel, with the patient in the supine position, using a landmark technique to target the relevant nerves for the blockage in group A.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 60
* Physical status: ASA I and II
* Elective operation, under general anaesthesia,

Exclusion Criteria:

* ASA above ll
* Patients with known uncontrolled comorbidities such as hypertension or Diabetes Mellites
* Coagulopathy, use of anti-coagulant or anti-platelet therapy.
* Known allergies to drugs used (Bupivacaine)
* Infection at the site of injection
* History of cranial nerve affection
* Emergency craniotomy.

Primary outcomes:
measure: intra-operative hemodynamic stability
timeFrame: intra-operatively
Secondary outcomes:
measure: fentanyl consumption
timeFrame: intra-operatively
Other outcomes:
measure: post-operative pain
timeFrame: 1 hour post-operatively
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Hegazy
role: PRINCIPAL_INVESTIGATOR
References: