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

ConditionScalp Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBangladesh Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgical site infiltration with plain bupivacaine

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Group Surgical site infiltration (SSI)Active comparator 1 intervention
Group B: Group Scalp blockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity by Numeric Rating Scale (NRS)

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

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

Secondary outcomes

1

Total consumption of morphine sulfate(mg) in 24 hours

Time frame
24 hours

Other outcomes

Sponsors and contacts

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