NCT07496632

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Bangladesh Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Scalp Block

Interventions

Type	Name	Description
PROCEDURE	Surgical site infiltration with plain bupivacaine	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
PROCEDURE	Scalp block with plain bupivacaine	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-03-27
• Last updated: 2026-04-01