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

February 14, 2026 updated by: Dileep Kumar, Aga Khan University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous Morphine
Participants receive intravenous Morphine 0.1mg/kg at induction.
Drug: Morphine

Drug: Morphine

Dose: 0.1 mg/kg

Route: Intravenous

Timing: At induction of anesthesia

Other Names:
  • Opioid
  • Systemic Analgesia
Experimental: Bilateral Scalp Nerve Block (SNB)
Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.
Procedure: Scalp nerve block

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
Drug: Lidocaine

Concentration: 0.1%

Route: Local infiltration

Used as part of scalp block mixture

Drug: Ropivacaine

Concentration: 0.25%

Route: Local infiltration

Used as part of scalp block mixture

Drug: Epinephrine (Adrenaline)

Concentration: 1:200,000

Route: Local infiltration

Used as vasoconstrictor adjunct

Drug: Dexamethasone

Dose: 4 mg

Route: Local Infiltration

Used as adjunct to prolong block duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative Period- from induction of anesthesia until skin closure.
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.
Intraoperative Period- from induction of anesthesia until skin closure.
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.
Intraoperative Period- from induction of anesthesia until skin closure.
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.
Intraoperative Period- from induction of anesthesia until skin closure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-24 hours postoperatively
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.
0-24 hours postoperatively
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:

  1. = Awake and alert
  2. = Drowsy, responsive to verbal stimuli
  3. = Drowsy, arousable to physical stimuli
  4. = Unarousable Higher scores indicate deeper sedation.
0-24 hours postoperatively
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

  1. Mild nausea
  2. Severe nausea with retching
  3. Vomiting
0-24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Dileep Kumar, MBBS, FCPS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC NUMBER- 2025-9126-34025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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