A Phase 4 interventional study of Scalp nerve block and Morphine in Supratentorial Tumors, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Aga Khan University · Phase 4, Interventional, and Supportive care
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.
22 studies on the registry are indexed under Supratentorial Neoplasms; 3 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 20 interventional studies indexed under Supratentorial Neoplasms.
Browse Supratentorial Neoplasms studies →Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive intravenous Morphine 0.1mg/kg at induction.
Drug: Morphine
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
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
Drug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia
Also known as: Opioid, Systemic Analgesia
Concentration: 0.1% Route: Local infiltration Used as part of scalp block mixture
Concentration: 0.25% Route: Local infiltration Used as part of scalp block mixture
Concentration: 1:200,000 Route: Local infiltration Used as vasoconstrictor adjunct
Dose: 4 mg Route: Local Infiltration Used as adjunct to prolong block duration
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative Period- from induction of anesthesia until skin closure.
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.
Time frame: 0-24 hours postoperatively
Total Postoperative Morphine Consumption in First 24 Hours
Total cumulative morphine consumption (mg) administered within the first 24 hours after surgery.
Time frame: 0-24 hours postoperatively
Postoperative Sedation Score Measured by 4-Point Sedation Scale
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.
Time frame: 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 1. Mild nausea 2. Severe nausea with retching 3. Vomiting
Time frame: 0-24 hours postoperatively
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Lidocaine · Ropivacaine · Epinephrine · Dexamethasone