Effects of SCALP Block on Postoperative Analgesia in Craniotomy Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
Patients undergoing craniotomy surgery often experience severe postoperative pain. This pain can affect the patient's hemodynamics, disrupt sleep patterns, and prolong hospital stays. Sudden increases in heart rate and blood pressure due to pain may lead to elevated intracranial pressure in patients, potentially causing morbidity and mortality. Opioids are commonly used to mitigate hemodynamic fluctuations and reduce postoperative pain; however, they may delay recovery, contribute to excessive sedation, and affect postoperative neurological examinations. Additionally, opioids have adverse effects such as nausea, vomiting, and respiratory depression. Alleviating hemodynamic instability and postoperative pain are critical concerns for neuro anesthesiologists. Regional analgesia techniques are employed in neurosurgery patients because they minimize anesthesia requirements, alleviate pain, and allow for neurological assessment with a lower incidence of systemic complications.The scalp block was developed due to its potential benefits as an effective regional anesthesia technique that supports the advancement of delicate brain surgeries such as functional and microsurgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2024
CompletedNovember 12, 2024
November 1, 2024
1 month
September 7, 2024
November 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Scalp
Our primary objective is to evaluate postoperative numerical rating scale scores in patients undergoing craniotomy surgery with a SCALP block. (Numerical rating scale score 0-10 point. 0= Very Bad, 10= Very Good
One day
Study Arms (2)
control group
ACTIVE COMPARATORAfter the surgery was completed, each patient received 3 mg of morphine IV and 8 mg of dexamethasone IV. Upon transfer to the intensive care unit, patients were administered 1 g of paracetamol IV three times a day and 20 mg of tenoxicam IV twice daily.
scalp block
OTHERAfter the surgical procedure, patients in Group S were placed in a semi-sitting position. Following skin antisepsis with 5% povidone-iodine, a sterile drape was applied. A circumferential scalp block with 2 cc of 0.25% bupivacaine was done on each of the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves that supply the forehead and scalp with sensory information. The procedure was performed bilaterally. The supratrochlear and supraorbital nerves were blocked at the brow, close to the upper middle edge orbit, and over the supraorbital notch that could be felt. The zygomaticotemporal nerve was blocked between the posterior edge of the zygomatic arch. The auriculotemporal nerve was blocked at the level of the tragus. The greater and lesser occipital nerves were blocked at the medial and lateral thirds of the superior nuchal line.
Interventions
After the surgical procedure, patients in Group S were placed in a semi-sitting position. Following skin antisepsis with 5% povidone-iodine, a sterile drape was applied. A circumferential scalp block with 2 cc of 0.25% bupivacaine was done on each of the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves that supply the forehead and scalp with sensory information. The procedure was performed bilaterally. The supratrochlear and supraorbital nerves were blocked at the brow, close to the upper middle edge orbit, and over the supraorbital notch that could be felt. The zygomaticotemporal nerve was blocked between the posterior edge of the zygomatic arch. The auriculotemporal nerve was blocked at the level of the tragus. The greater and lesser occipital nerves were blocked at the medial and lateral thirds of the superior nuchal line.
Eligibility Criteria
You may qualify if:
- years
- General anesthesia
- American Society of Anesthesiologists physical status I-III
You may not qualify if:
- Contraindications to regional anesthesia
- Coagulation disorders
- Known allergy to local anesthetics
- Infections at the block site
- Pregnant patients
- Emergency cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konya City Hospital
Konya, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist, Department of Anesthesiology, Konya City Hospital, M.D
Study Record Dates
First Submitted
September 7, 2024
First Posted
September 19, 2024
Study Start
October 7, 2024
Primary Completion
November 11, 2024
Study Completion
November 11, 2024
Last Updated
November 12, 2024
Record last verified: 2024-11