Craniotomy, Dexamethasone, Lidocaine, Scalp Incision Infiltration
Conditions
Brief summary
This study aimed to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (xylocaine) could achieve superior postoperative analgesic effects to a local anesthetic (xylocaine) plus epinephrine in adult patients undergoing a craniotomy.
Detailed description
Approximately 55-87% of patients undergoing craniotomy experience moderate to severe pain during the first 48 hours after surgery, which negatively influences their postoperative rehabilitation. Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of dexamethasone to LIA for patients receiving craniotomy.
Interventions
DRUGXylocaine plus Dexamethasone
Patients received the incision site infiltration of 2% xylocaine plus dexamethasone.
DRUGXylocaine plus epinephrine
Patients received the incision site infiltration of 2% xylocaine plus epinephrine.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients age between 20 and 60 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I and II * Scheduled for elective supratentorial tumor craniotomy under general anesthesia.
Exclusion criteria
* Patients with known hypersensitivity to lidocaine or dexamethasone. * Chronic corticosteroid therapy. * Pre-existing coagulopathy. * Significant hepatic or renal impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 48 hours postoperatively | Degree of pain was measured using the Numerical Rating Scale after surgery (numeric rating scale (NRS); 0 = no pain, 10 = worst imaginable pain) |
| Total opioid consumption | 48 hours postoperatively | Total postoperative opioid (fentanyl) consumption was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure | Till the end of surgery (Up to 2 hours) | Mean arterial pressure was measured during induction and every fifteen minutes after that. |
| Heart rate | Till the end of surgery (Up to 2 hours) | Heart rate was measured during induction and every fifteen minutes after that |
| Time to first postoperative analgesic request | 48 hours postoperatively | The time to the first postoperative analgesic request was recorded from the end of surgery till the first dose of fentanyl administered. |
| Incidence of postoperative nausea and vomiting | 48 hours postoperatively | Incidence of postoperative nausea and vomiting was recorded. |
| Degree of patient satisfaction | 48 hours postoperatively | Degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied) |
Countries
Egypt
Outcome results
None listed