NCT06588751

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

September 7, 2024

Last Update Submit

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 COMPARATOR

After 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.

Other: Scalp block

scalp block

OTHER

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.

Other: Scalp block

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.

control groupscalp block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
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

Locations