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

NCT07496632 | Not Yet Recruiting DMC

• 1 other identifier: #6026
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Scalp Block

Keywords

Scalp Block; Intraoperative Hemodynamic Responses; Postoperative Analgesia; Craniotomy

Outcome Measures

Primary Outcomes (5)

• 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.

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

• Changes in heart rate (beats per minute)

  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))

• Change in Systoloic Blood Pressure (SBP) (in mmHg)

  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))

• Change in diastolic blood pressure (DBP) (in mmHg)

  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))

• Change in mean arteial pressure (MAP) (in mmHg)

  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

  24 hours

Study Arms (2)

Group Surgical site infiltration (SSI)

ACTIVE COMPARATOR

Participants in this group will receive standard general anesthesia for elective supratentorial craniotomy. In addition, local anesthetic will be administered via surgical site infiltration.

Procedure: Surgical site infiltration with plain bupivacaine

Group Scalp block

EXPERIMENTAL

Participants in this group will receive standard general anesthesia for elective supratentorial craniotomy. In addition, they will receive an ultrasound-guided scalp block targeting the major nerves of the scalp.

Procedure: Scalp block with plain bupivacaine

Interventions

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

Group Surgical site infiltration (SSI)

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.

Group Scalp block

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Related Publications (23)

• Zetlaoui PJ, Gauthier E, Benhamou D. Ultrasound-guided scalp nerve blocks for neurosurgery: A narrative review. Anaesth Crit Care Pain Med. 2020 Dec;39(6):876-882. doi: 10.1016/j.accpm.2020.06.019. Epub 2020 Oct 8.

  PMID: 33039656 BACKGROUND

• Yildiz K, Bicer C, Aksu R, Dogru K, Madenoglu H, Boyaci A. A comparison of 1 minimum alveolar concentration desflurane and 1 minimum alveolar concentration isoflurane anesthesia in patients undergoing craniotomy for supratentorial lesions. Curr Ther Res Clin Exp. 2011 Apr;72(2):49-59. doi: 10.1016/j.curtheres.2011.03.001.

  PMID: 24648575 BACKGROUND

• Vadivelu N, Kai AM, Tran D, Kodumudi G, Legler A, Ayrian E. Options for perioperative pain management in neurosurgery. J Pain Res. 2016 Feb 10;9:37-47. doi: 10.2147/JPR.S85782. eCollection 2016.

  PMID: 26929661 BACKGROUND

• Uyar AS, Yagmurdur H, Fidan Y, Topkaya C, Basar H. Dexmedetomidine attenuates the hemodynamic and neuroendocrinal responses to skull-pin head-holder application during craniotomy. J Neurosurg Anesthesiol. 2008 Jul;20(3):174-9. doi: 10.1097/ANA.0b013e318177e5eb.

  PMID: 18580347 BACKGROUND

• Theerth KA, Sriganesh K, Reddy KM, Chakrabarti D, Umamaheswara Rao GS. Analgesia Nociception Index-guided intraoperative fentanyl consumption and postoperative analgesia in patients receiving scalp block versus incision-site infiltration for craniotomy. Minerva Anestesiol. 2018 Dec;84(12):1361-1368. doi: 10.23736/S0375-9393.18.12837-9. Epub 2018 Jul 9.

  PMID: 29991223 BACKGROUND

• Theerth KA, Sriganesh K, Chakrabarti D, Reddy KRM, Rao GSU. Analgesia nociception index and hemodynamic changes during skull pin application for supratentorial craniotomies in patients receiving scalp block versus pin-site infiltration: A randomized controlled trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):306-311. doi: 10.4103/sja.SJA_812_18.

  PMID: 31572074 BACKGROUND

• Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.

  PMID: 8942596 BACKGROUND

• Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558.

  PMID: 26903671 BACKGROUND

• Papangelou A, Radzik BR, Smith T, Gottschalk A. A review of scalp blockade for cranial surgery. J Clin Anesth. 2013 Mar;25(2):150-9. doi: 10.1016/j.jclinane.2012.06.024. Epub 2013 Jan 23.

  PMID: 23352875 BACKGROUND

• Nanayakkara D, Manawaratne R, Sampath H, Vadysinghe A, Peiris R. Supraorbital nerve exits: positional variations and localization relative to surgical landmarks. Anat Cell Biol. 2018 Mar;51(1):19-24. doi: 10.5115/acb.2018.51.1.19. Epub 2018 Mar 28.

  PMID: 29644106 BACKGROUND

• Misra S, Koshy T, Unnikrishnan KP, Suneel PR, Chatterjee N. Gabapentin premedication decreases the hemodynamic response to skull pin insertion in patients undergoing craniotomy. J Neurosurg Anesthesiol. 2011 Apr;23(2):110-7. doi: 10.1097/ANA.0b013e3181da3c3b.

  PMID: 20479668 BACKGROUND

• Kondavagilu SR, Pujari VS, Chadalawada MV, Bevinguddaiah Y. Low Dose Dexmedetomidine Attenuates Hemodynamic Response to Skull Pin Holder Application. Anesth Essays Res. 2017 Jan-Mar;11(1):57-61. doi: 10.4103/0259-1162.200229.

  PMID: 28298757 BACKGROUND

• Kara AK, Sari S, Tan KB, Topcu A, Donmez N, Turgut M, Aydin ON. Efficacy of selective scalp nerve blocks for postoperative pain in craniotomy: A single-center experience. Agri. 2025 Oct;37(4):240-242. doi: 10.14744/agri.2023.93708.

  PMID: 41042044 BACKGROUND

• Kamal MM, Chowdhury IH, Islam MI, Hossain MJ, Akhtaruzzaman AK. Effect of Intravenous Paracetamol with Bupivacaine Scalp Nerve Block on Haemodynamics Response as Well as Anaesthetic Requirements during Supratentorial Craniotomies. Mymensingh Med J. 2020 Apr;29(2):341-350.

  PMID: 32506088 BACKGROUND

• Hans P, Brichant JF, Dewandre PY, Born JD, Lamy M. Effects of two calculated plasma sufentanil concentrations on the hemodynamic and bispectral index responses to Mayfield head holder application. J Neurosurg Anesthesiol. 1999 Apr;11(2):81-5. doi: 10.1097/00008506-199904000-00002.

  PMID: 10213433 BACKGROUND

• Guilfoyle MR, Helmy A, Duane D, Hutchinson PJA. Regional scalp block for postcraniotomy analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 May;116(5):1093-1102. doi: 10.1213/ANE.0b013e3182863c22. Epub 2013 Mar 11.

  PMID: 23477962 BACKGROUND

• Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2.

  PMID: 19262392 BACKGROUND

• Fu PH, Teng IC, Liu WC, Chen IW, Ho CN, Hsing CH, Sun CK, Hung KC. Association of scalp block with intraoperative hemodynamic profiles and postoperative pain outcomes at 24-48 hours following craniotomy: An updated systematic review and meta-analysis of randomized controlled studies. Pain Pract. 2023 Feb;23(2):136-144. doi: 10.1111/papr.13167. Epub 2022 Oct 6.

  PMID: 36176201 BACKGROUND

• Doblar DD, Lim YC, Baykan N, Frenette L. A comparison of alfentanil, esmolol, lidocaine, and thiopental sodium on the hemodynamic response to insertion of headrest skull pins. J Clin Anesth. 1996 Feb;8(1):31-5. doi: 10.1016/0952-8180(95)00169-7.

  PMID: 8695076 BACKGROUND

• Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.

  PMID: 33060491 BACKGROUND

• Can BO, Bilgin H. Effects of scalp block with bupivacaine versus levobupivacaine on haemodynamic response to head pinning and comparative efficacies in postoperative analgesia: A randomized controlled trial. J Int Med Res. 2017 Apr;45(2):439-450. doi: 10.1177/0300060516665752. Epub 2017 Mar 7.

  PMID: 28415943 BACKGROUND

• Bharne S, Bidkar PU, Badhe AS, Parida S, Ramesh AS. Comparison of intravenous labetalol and bupivacaine scalp block on the hemodynamic and entropy changes following skull pin application: A randomized, open label clinical trial. Asian J Neurosurg. 2016 Jan-Mar;11(1):60-5. doi: 10.4103/1793-5482.165801.

  PMID: 26889282 BACKGROUND

• Arshad A, Shamim MS, Waqas M, Enam H, Enam SA. How effective is the local anesthetic infiltration of pin sites prior to application of head clamps: A prospective observational cohort study of hemodynamic response in patients undergoing elective craniotomy. Surg Neurol Int. 2013 Jul 18;4:93. doi: 10.4103/2152-7806.115237. eCollection 2013.

  PMID: 23956936 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Kazi Mahzabin Arin, MD

CONTACT

+8801754057689; kazimahzabinarin@bsmmu.edu.bd

AKM Akhtaruzzaman, MD

CONTACT

akm.akhtaruzzaman@bmu.ac.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share