Comparison of Systemic Opioid (Morphine) and Pre-Incision Bilateral Scalp Nerve Block for Pain Management in Craniotomy Patients

NCT07425678 | Completed Phase 4

• 1 other identifier: ERC NUMBER- 2025-9126-34025
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Supratentorial Tumors

Keywords

Scalp Nerve Block; Craniotomy; Opioid-Sparing Technique; Regional versus Morphine

Outcome Measures

Primary Outcomes (4)

• 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.

  Intraoperative Period- from induction of anesthesia until skin closure.

Secondary Outcomes (4)

• Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

  0-24 hours postoperatively

• Total Postoperative Morphine Consumption in First 24 Hours

  0-24 hours postoperatively

• Postoperative Sedation Score Measured by 4-Point Sedation Scale

  0-24 hours postoperatively

• Incidence of Postoperative Nausea/ Vomiting Within 24 Hours

  0-24 hours postoperatively

Study Arms (2)

Intravenous Morphine

ACTIVE COMPARATOR

Participants receive intravenous Morphine 0.1mg/kg at induction.

Drug: Morphine

Bilateral Scalp Nerve Block (SNB)

EXPERIMENTAL

Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.

Procedure: Scalp nerve block; Drug: Lidocaine; Drug: Ropivacaine; Drug: Epinephrine (Adrenaline); Drug: Dexamethasone

Interventions

Scalp nerve block PROCEDURE

Bilateral block of the following nerves: * Supraorbital nerve * Supratrochlear nerve * Auriculotemporal nerve * Zygomaticotemporal nerve * Greater occipital nerve * Lesser occipital nerve

Also known as: SNB, Regional Nerve Block

Bilateral Scalp Nerve Block (SNB)

Morphine DRUG

Drug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia

Also known as: Opioid, Systemic Analgesia

Intravenous Morphine

Epinephrine (Adrenaline) DRUG

Concentration: 1:200,000 Route: Local infiltration Used as vasoconstrictor adjunct

Bilateral Scalp Nerve Block (SNB)

Lidocaine DRUG

Concentration: 0.1% Route: Local infiltration Used as part of scalp block mixture

Bilateral Scalp Nerve Block (SNB)

Ropivacaine DRUG

Concentration: 0.25% Route: Local infiltration Used as part of scalp block mixture

Bilateral Scalp Nerve Block (SNB)

Dexamethasone DRUG

Dose: 4 mg Route: Local Infiltration Used as adjunct to prolong block duration

Bilateral Scalp Nerve Block (SNB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years to 75 years,
• American Society of Anesthesiologists class I-III,
• Scheduled for supratentorial craniotomy.

You may not qualify if:

• Patient with Glasgow Coma Score (GCS) of less than 15,
• Inability to understand the Visual analog scale (VAS)
• Allergic to study drugs (Morphine and local anesthetics)
• Patient chronically treated with narcotic medications.
• History of Liver dysfunction

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (5)

• O.K. Dilmen, E.F. Akcil, Y. Tunali, et al., Postoperative analgesia for supratentorial craniotomy, Clin. Neurol. Neurosurg. 146 (2016) 90-95.

  BACKGROUND

• Jayaram K, Srilata M, Kulkarni D, Ramachandran G (2016) Regional anesthesia to scalp for craniotomy: innovation with innervations. J Neurosurganesthesiol 28(1):32-37

  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.

  BACKGROUND

• Nguyen A, Girard F, Boudreault D, et al. Scalp nerve blocks decreases the severity of pain following craniotomy. Anesth Analg 2001;93:1272- 6.

  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.

  PMID: 17056961 BACKGROUND

MeSH Terms

Conditions

Supratentorial Neoplasms

Interventions

Morphine; Analgesics, Opioid; Lidocaine; Ropivacaine; Epinephrine; Dexamethasone

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Dileep Kumar, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: It is a double blinded, randomized controlled trial with non-probability consecutive sampling

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 23, 2026
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 30, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)