Ain Shams University
Cairo, Cairo Governorate, 11111, Egypt
NCT Number: NCT06951230
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
Looking for future studies?
Notify Me20 year–60 year
All sexes
Interventional
Phase 1
Cairo, Cairo Governorate, 11111, Egypt
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation.
The scalp block procedure is performed with the patient in the supine position, utilizing surface landmarks for guidance. The local anesthetic is injected into the nerves after careful aspiration and under strict aseptic technique. The nerves that are typically injected include the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, as well as the lesser and greater occipital nerves, with or without the inclusion of the third occipital nerve. The volume of 0.5% bupivacaine injected should not exceed 2 ml at each site.
Time frame: intra-operatively
Recording the mean arterial blood pressure and heart rate readings will be obtained before induction , on skin pinning, on skin incision , 1 hour post induction, after 2hours and every hour hour till the end of the surgery
Time frame: intra-operatively
The total amount of fentanyl required along the operation will be recorded to detect the effect of the scalp block on narcotic consumption.
Time frame: 1 hour post-operatively
The pain is assessed post operatively in all patients 1 hour post-operatively using visual analogue scale a scale from 0 to 10 , where 0 is no pain and 10 is the worst unbearable pain. the amount of opiods needed will be recorded to detect the effect of the scalp block on postoperative pain control and decreasing narcotic demand.
Ain Shams University
Other
The Efficacy of Scalp Block Versus Intravenous Fentanyl in Pain Control Intraoperatively in Craniotomy Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06026527
Neurologic Manifestations, Pain
Kathmandu, Bagmati, Nepal
View Trial DetailsNCT06717672
Neurologic Manifestations, Pain
Karachi, Sindh, Pakistan
View Trial DetailsNCT06387849
Anxiety Disorders, Mental Disorders
Ben Arous, Tunisia
View Trial DetailsNCT03887650
Agnosia, Nervous System Diseases
Hartford, Connecticut, United States
View Trial Details