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The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy.
The main questions this study aims to answer are:
Does pre-incision bilateral scalp nerve block provide better intraoperative hemodynamic stability compared to systemic opioids?
Does it result in lower postoperative pain scores and reduced opioid consumption during the first 24 hours after surgery?
Researchers will compare Group M (systemic morphine) with Group S (bilateral scalp nerve block) to see if the scalp nerve block offers superior analgesia and fewer opioid-related side effects.
Participants will:
Be randomly assigned to receive either systemic morphine or bilateral scalp nerve block before incision.
Undergo standard general anesthesia for craniotomy.
Have postoperative pain managed using a patient-controlled analgesia (PCA) morphine pump and be monitored for 24 hours for pain, sedation, and nausea/vomiting scores
This double blinded, randomized controlled trial was conducted at Aga Khan University Hospital, Karachi, over a period of three to six months after obtaining approval from the institutional ethics committee. Non-probability consecutive sampling was used.
Eligible patients were randomly assigned using computer-generated randomization into two groups: Group M (morphine) and Group S (scalp nerve block). Pre-operatively, all patients were given explanations of the visual analogue scale (VAS) scores for pain assessment and how to operate the patient-controlled analgesia (PCA) machine for post-operative analgesia. Baseline heart rate and blood pressure were recorded after applying standard ASA monitors. Group M was given IV Morphine at induction 0.1mg/kg. In Group S, a bilateral scalp nerve block was performed after arterial line insertion using a mixture of lidocaine 0.1%, ropivacaine 0.25%, adrenaline 1:200,000, and dexamethasone 4 mg. The supraorbital, supratrochlear, auriculotemporal, zygomaticotemporal, greater, and lesser occipital nerves were blocked. In Group M, only pin sites were infiltrated with the same solution.
Intraoperative heart rate, systolic, diastolic, and mean arterial pressures were recorded at multiple surgical stages. Postoperatively, all patients received PCA morphine (1 mg/ml, 1 mg bolus, 10-minute lockout, no background infusion). Pain (VAS), sedation, and nausea/vomiting scores were assessed up to 24 hours postoperatively by a blinded observer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Morphine | Active Comparator | Participants receive intravenous Morphine 0.1mg/kg at induction. |
|
| Bilateral Scalp Nerve Block (SNB) | Experimental | Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalp nerve block | Procedure | Bilateral block of the following nerves:
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Heart Rate Response to Noxious Stimuli | Heart rate (beats per minute) will be recorded on various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy. | Intraoperative Period- from induction of anesthesia until skin closure. |
| Intraoperative Systolic Blood Pressure Response to Noxious Stimuli | Systolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy. | Intraoperative Period- from induction of anesthesia until skin closure. |
| Intraoperative Diastolic Blood Pressure Response to Noxious Stimuli | Diastolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy. | Intraoperative Period- from induction of anesthesia until skin closure. |
| Intraoperative Mean Arterial Pressure Response to Noxious Stimuli | Mean arterial pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) | Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where: 0 = No pain 10 = Worst imaginable pain Higher scores indicate worse pain. Pain will be assessed at predefined intervals within the first 24 hours after surgery. | 0-24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dileep Kumar, MBBS, FCPS | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University Hospital | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27164511 | Background | Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4. | |
| 26083426 | Background | Jayaram K, Srilata M, Kulkarni D, Ramachandran G. Regional Anesthesia to Scalp for Craniotomy: Innovation With Innervation. J Neurosurg Anesthesiol. 2016 Jan;28(1):32-7. doi: 10.1097/ANA.0000000000000184. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2024 |
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It is a double blinded, randomized controlled trial with non-probability consecutive sampling
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|
| Morphine | Drug | Drug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia |
|
|
| Lidocaine | Drug | Concentration: 0.1% Route: Local infiltration Used as part of scalp block mixture |
|
| Ropivacaine | Drug | Concentration: 0.25% Route: Local infiltration Used as part of scalp block mixture |
|
| Epinephrine (Adrenaline) | Drug | Concentration: 1:200,000 Route: Local infiltration Used as vasoconstrictor adjunct |
|
| Dexamethasone | Drug | Dose: 4 mg Route: Local Infiltration Used as adjunct to prolong block duration |
|
| Intraoperative Period- from induction of anesthesia until skin closure. |
| Total Postoperative Morphine Consumption in First 24 Hours | Total cumulative morphine consumption (mg) administered within the first 24 hours after surgery. | 0-24 hours postoperatively |
| Postoperative Sedation Score Measured by 4-Point Sedation Scale | Sedation will be assessed using a 4-point sedation scale:
| 0-24 hours postoperatively |
| Incidence of Postoperative Nausea/ Vomiting Within 24 Hours | Nausea/Vomiting will be assessed using a four-point scale: 0= No nausea and vomiting
| 0-24 hours postoperatively |
| Background | Tuchinda, Lawan & Somboonviboon, Wanna & Supbornsug, Kaew & Worathongchai, Sukhumakorn & Limutaitip, Supodjanee. (2010). Bupivacaine scalp nerve block: Hemodynamic response during craniotomy, intraoperative and post-operative analgesia. Asian Biomedicine. 4. 10.2478/abm-2010-0031. |
| 11682413 | Background | Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048. |
| 17056961 | Background | Ayoub C, Girard F, Boudreault D, Chouinard P, Ruel M, Moumdjian R. A comparison between scalp nerve block and morphine for transitional analgesia after remifentanil-based anesthesia in neurosurgery. Anesth Analg. 2006 Nov;103(5):1237-40. doi: 10.1213/01.ane.0000244319.51957.9f. |
| Feb 14, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2024 | Feb 14, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015173 | Supratentorial Neoplasms |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D000701 | Analgesics, Opioid |
| D008012 | Lidocaine |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
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