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Completed

NCT Number: NCT07425678

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

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

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Key information

Conditions

Supratentorial Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Supratentorial Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Scalp nerve block

Procedure

Bilateral block of the following nerves:

  • Supraorbital nerve
  • Supratrochlear nerve
  • Auriculotemporal nerve
  • Zygomaticotemporal nerve
  • Greater occipital nerve
  • Lesser occipital nerve

Other names: SNB, Regional Nerve Block

Morphine

Drug

Drug: Morphine

Dose: 0.1 mg/kg

Route: Intravenous

Timing: At induction of anesthesia

Other names: Opioid, Systemic Analgesia

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

Primary outcomes

  1. Intraoperative Heart Rate Response to Noxious Stimuli

    Time frame: Intraoperative Period- from induction of anesthesia until skin closure.

    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.

  2. Intraoperative Systolic Blood Pressure Response to Noxious Stimuli

    Time frame: Intraoperative Period- from induction of anesthesia until skin closure.

    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.

  3. Intraoperative Diastolic Blood Pressure Response to Noxious Stimuli

    Time frame: Intraoperative Period- from induction of anesthesia until skin closure.

    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.

  4. Intraoperative Mean Arterial Pressure Response to Noxious Stimuli

    Time frame: Intraoperative Period- from induction of anesthesia until skin closure.

    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.

Secondary outcomes

  1. Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: 0-24 hours postoperatively

    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.

  2. Total Postoperative Morphine Consumption in First 24 Hours

    Time frame: 0-24 hours postoperatively

    Total cumulative morphine consumption (mg) administered within the first 24 hours after surgery.

  3. Postoperative Sedation Score Measured by 4-Point Sedation Scale

    Time frame: 0-24 hours postoperatively

    Sedation will be assessed using a 4-point sedation scale:

    • = Awake and alert
    • = Drowsy, responsive to verbal stimuli
    • = Drowsy, arousable to physical stimuli
    • = Unarousable Higher scores indicate deeper sedation.

  4. Incidence of Postoperative Nausea/ Vomiting Within 24 Hours

    Time frame: 0-24 hours postoperatively

    Nausea/Vomiting will be assessed using a four-point scale:

    0= No nausea and vomiting

    • Mild nausea
    • Severe nausea with retching
    • Vomiting

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Perioperative Analgesic Management Using Conventional Versus Regional Nerve Block in Craniotomy Surgeries in Lower Middle-Income Class Countries

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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