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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
62
Bilateral block of the following nerves: * Supraorbital nerve * Supratrochlear nerve * Auriculotemporal nerve * Zygomaticotemporal nerve * Greater occipital nerve * Lesser occipital nerve
Drug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia
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
Aga Khan University Hospital
Karachi, Sindh, Pakistan
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
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