Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07496632

Effect of Scalp Block on Intraoperative Hemodynamics and Postoperative Pain in Craniotomy Patients"

The goal of this clinical trial is to learn if an ultrasound-guided scalp block can improve intraoperative hemodynamic stability and provide better postoperative pain relief in adult patients undergoing elective supratentorial craniotomy. The main questions it aims to answer are:

Does ultrasound-guided scalp block reduce changes in heart rate and blood pressure during surgery compared with surgical site infiltration?

Does ultrasound-guided scalp block decrease postoperative pain and opioid requirements in the first 24 hours after craniotomy?

Researchers will compare patients receiving an ultrasound-guided scalp block to those receiving standard surgical site infiltration to see if the scalp block provides better perioperative hemodynamic control and postoperative analgesia.

Participants will:

Receive general anesthesia with either ultrasound-guided scalp block or surgical site infiltration

Have heart rate, blood pressure, and other hemodynamic parameters monitored throughout surgery

Receive standard postoperative pain management, with pain scores recorded at 0, 2, 6, 12, and 24 hours

Receive opioids as needed based on pain scores, with total opioid consumption and time to first analgesic dose recorded

Be monitored for adverse events, including nausea, vomiting, sedation, and block-related complications

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This clinical trial is designed to evaluate whether an ultrasound-guided scalp block improves outcomes in adult patients undergoing elective craniotomy. Craniotomy, a surgical procedure to access the brain, can be associated with significant pain and stress responses during and after surgery. Painful events such as intubation, placement of skull pins, skin incision, and manipulation of the scalp and dura can cause rapid increases in heart rate and blood pressure, which may be harmful, especially in patients with brain injuries or compromised cerebral blood flow.

Currently, these hemodynamic changes are often managed with general anaesthesia and systemic medications such as opioids. However, opioids can delay recovery, cause nausea and vomiting, and interfere with neurological assessments after surgery. Regional anaesthesia techniques, like a scalp block, can reduce the body's stress response to surgery, provide better pain relief, and decrease the need for systemic pain medications. Ultrasound guidance allows anesthesiologists to locate nerves more accurately and perform the block safely, reducing potential complications.

In this study, participants will be randomly assigned to one of two groups. One group will receive a standard surgical site infiltration with local anaesthetic, while the other group will receive an ultrasound-guided scalp block in addition to general anaesthesia. All participants will be closely monitored during surgery, with measurements of heart rate, blood pressure, and other vital signs taken at key points, including before induction, during intubation, at skull pin placement, at skin incision, and at skin closure.

After surgery, participants will receive routine pain management and will be monitored for the first 24 hours. Pain levels will be recorded at multiple time points, and the total use of opioid pain medications, time to first analgesic, and any side effects or complications will be documented.

The main goal of the study is to determine whether the ultrasound-guided scalp block can provide better control of heart rate and blood pressure during surgery and improve postoperative pain relief compared with surgical site infiltration. Secondary goals include assessing the amount of pain medication needed after surgery and the incidence of any side effects, such as nausea, vomiting, or sedation.

Results from this study may help improve patient comfort, reduce complications, and optimize pain management strategies for patients undergoing brain surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-64 years.
  • ASA (American Society of Anesthesiologists) physical status I or II.
  • Patients scheduled for elective supratentorial craniotomy.
  • BMI of 18 to 30 kg/m².
  • GCS score of 9 to 15.

Exclusion criteria

  • Patient with instable blood pressure and heart rate.
  • Known allergy or hypersensitivity to local anesthetics.
  • Coagulation disorders or current anticoagulant therapy.
  • Infection at the injection site or systemic infection.
  • Patients with open skull defects.

Treatment and study plan

Surgical site infiltration with plain bupivacaine

Procedure

Participants receiving this intervention will undergo local anesthetic infiltration at the planned surgical sites in addition to standard general anesthesia for elective supratentorial craniotomy.

Drug: Bupivacaine 0.5% plain solution

Dosage: 10-15 ml along the incision line plus 5 ml at each pin insertion site

Dosage Form: Injectable solution

Route: Subcutaneous and deep infiltration into the scalp

Timing: Single administration immediately after induction of general anesthesia, prior to surgical incision

Scalp block with plain bupivacaine

Procedure

Participants receiving this intervention will undergo ultrasound-guided regional nerve blockade of the scalp in addition to standard general anesthesia for elective supratentorial craniotomy. The procedure targets the supratrochlear, supraorbital, auriculotemporal, postauricular branches of the greater auricular nerve, and the greater, lesser, and third occipital nerves.

Primary outcomes

  1. Postoperative pain intensity by Numeric Rating Scale (NRS)

    Time frame: Immediately after shifting to the recovery room, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours

    Scores range from 0 to 10, where 0 represents 'no pain' and 10 represents 'worst possible pain'. High scores indicate more pain.

  2. Changes in heart rate (beats per minute)

    Time frame: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))

  3. Change in Systoloic Blood Pressure (SBP) (in mmHg)

    Time frame: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))

  4. Change in diastolic blood pressure (DBP) (in mmHg)

    Time frame: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))

  5. Change in mean arteial pressure (MAP) (in mmHg)

    Time frame: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))

Secondary outcomes

  1. Total consumption of morphine sulfate(mg) in 24 hours

    Time frame: 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

AKM Akhtaruzzaman, MD

CONTACT

[email protected]

Kazi Mahzabin Arin, MD

CONTACT

[email protected]

+8801754057689

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

Efficacy of Scalp Block on Intraoperative Hemodynamic Responses and Postoperative Analgesia in Patients Undergoing Craniotomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Apr 1, 2026

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.