Scalp BlockNCT07496632
Effect of Scalp Block on Intraoperative Hemodynamics and Postoperative Pain in Craniotomy Patients"
A study testing Surgical site infiltration with plain bupivacaine and Scalp block with plain bupivacaine in people with Scalp Block, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Scalp Block
- What is being tested?
- Surgical site infiltration with plain bupivacaine and Scalp block with plain bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Apr 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
AKM Akhtaruzzaman, MD contact
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, 1000
Kazi Mahzabin Arin, MD, 01754057689, kazimahzabinarin@bmu.ac.bd
About this study
Official title: Efficacy of Scalp Block on Intraoperative Hemodynamic Responses and Postoperative Analgesia in Patients Undergoing Craniotomy
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?
Read more
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
Read the 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
- Being tested
- Surgical site infiltration with plain bupivacaine, Scalp block with plain bupivacaine
- Keywords
- Scalp Block, Intraoperative Hemodynamic Responses, Postoperative Analgesia, Craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical site infiltration with plain bupivacaineProcedure or 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 bupivacaineProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Scalp block with plain bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Scalp BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496632
- Sponsor's protocol ID
- #6026
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33039656Yildiz 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.
PubMed 24648575Vadivelu 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.
PubMed 26929661Uyar 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.
PubMed 18580347Theerth 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.
PubMed 29991223Theerth 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.
PubMed 31572074Pinosky 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.
PubMed 8942596Paul 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.
PubMed 26903671Papangelou 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.
PubMed 23352875Nanayakkara 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.
PubMed 29644106Misra 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.
PubMed 20479668Kondavagilu 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.
PubMed 28298757Kara 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.
PubMed 41042044Kamal 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.
PubMed 32506088Hans 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.
PubMed 10213433
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Scalp Block on Intraoperative Hemodynamic Responses and Postoperative Analgesia in Patients Undergoing Craniotomy
- ClinicalTrials.gov ID
- NCT07496632
- Acronym / sponsor ID
- #6026
- Conditions
- Scalp Block
- Keywords
- Scalp Block, Intraoperative Hemodynamic Responses, Postoperative Analgesia, Craniotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Surgical site infiltration (SSI) | Active comparator | Procedure: Surgical site infiltration with plain bupivacaineParticipants in this group will receive standard general anesthesia for elective supratentorial craniotomy. In addition, local anesthetic will be administered via surgical site infiltration. |
| Group Scalp block | Experimental | Procedure: Scalp block with plain bupivacaineParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical site infiltration with plain bupivacaineParticipants 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 or surgery | Group Surgical site infiltration (SSI) |
| Scalp block with plain bupivacaineParticipants 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. | Procedure or surgery | Group Scalp block |
Primary outcome
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.
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))
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))
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))
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))
1 secondary outcome
Total consumption of morphine sulfate(mg) in 24 hours
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 33039656Zetlaoui 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.
- Background: PubMed 24648575Yildiz 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.
- Background: PubMed 26929661Vadivelu 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.
- Background: PubMed 18580347Uyar 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.
- Background: PubMed 29991223Theerth 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.
- Background: PubMed 31572074Theerth 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.
- Background: PubMed 8942596Pinosky 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.
- Background: PubMed 26903671Paul 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.
- Background: PubMed 23352875Papangelou 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.
- Background: PubMed 29644106Nanayakkara 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.
- Background: PubMed 20479668Misra 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.
- Background: PubMed 28298757Kondavagilu 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AKM Akhtaruzzaman, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical site infiltration with plain bupivacaine and Scalp block with plain bupivacaine in people with Scalp Block, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazi Mahzabin Arin, MD (+8801754057689, kazimahzabinarin@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07496632, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.