Supratentorial Tumors
Conditions
Keywords
Scalp Nerve Block, Craniotomy, Opioid-Sparing Technique, Regional versus Morphine
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
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.
Interventions
PROCEDUREScalp nerve block
Bilateral block of the following nerves: * Supraorbital nerve * Supratrochlear nerve * Auriculotemporal nerve * Zygomaticotemporal nerve * Greater occipital nerve * Lesser occipital nerve
DRUGMorphine
Drug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia
DRUGLidocaine
Concentration: 0.1% Route: Local infiltration Used as part of scalp block mixture
DRUGRopivacaine
Concentration: 0.25% Route: Local infiltration Used as part of scalp block mixture
DRUGEpinephrine (Adrenaline)
Concentration: 1:200,000 Route: Local infiltration Used as vasoconstrictor adjunct
DRUGDexamethasone
Dose: 4 mg Route: Local Infiltration Used as adjunct to prolong block duration
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
It is a double blinded, randomized controlled trial with non-probability consecutive sampling
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Heart Rate Response to Noxious Stimuli | 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 Systolic Blood Pressure Response to Noxious Stimuli | 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 Diastolic Blood Pressure Response to Noxious Stimuli | 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 Mean Arterial Pressure Response to Noxious Stimuli | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) | 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. |
| Total Postoperative Morphine Consumption in First 24 Hours | 0-24 hours postoperatively | Total cumulative morphine consumption (mg) administered within the first 24 hours after surgery. |
| Postoperative Sedation Score Measured by 4-Point Sedation Scale | 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. |
| Incidence of Postoperative Nausea/ Vomiting Within 24 Hours | 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDileep Kumar, MBBS, FCPS
Aga Khan University
Outcome results
None listed