Dexmedetomidine, Adjuvant, Bupivacaine, Scalp Block, Postoperative Pain, Craniotomy
Conditions
Brief summary
This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.
Detailed description
Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation. The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.
Interventions
OTHERScalp block
Patients will receive a scalp block with bupivacaine alone.
OTHERScalp block + Dexmedetomidine
Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I or II. * Undergoing supratentorial elective planned craniotomies.
Exclusion criteria
* Patients refusal. * History of known allergy to the used local anesthetic or dexmedetomidine. * Bleeding disorders. * Evidence of local infection at the site of injection. * Emergency craniotomy. * Psychotic disorder. * Patients who will not be extubated in the operating room after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative postoperative morphine consumption | 24 hours postoperatively | If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure | 24 hours postoperatively | Mean arterial pressure will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and postoperatively at 2, 4, 6,12, and 24 hours postoperatively. |
| Heart rate | 24 hours postoperatively | Heart rate will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and 2, 4, 6, 12, and 24 hours postoperatively. |
| Degree of pain | 24 hours postoperatively | Pain intensity will be evaluated on a 0-10 visual analog scale (VAS). The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The VAS score will be recorded at baseline (after admission to PACU), then after 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively. |
| Time for 1st rescue analgesia | 24 hours postoperatively | Time for 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated. |
| Incidence of complications | 24 hours postoperatively | Incidence of complications such as postoperative nausea and vomiting, respiratory depression, or any other complication will be recorded. |
Countries
Egypt
Contacts
Primary ContactOmar A Khiralla, MBBCH
Outcome results
None listed