REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

Study Overview
=================
Brief Summary
-----------------
Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the backdrop of perioperative glucocorticoid deserves further clarification.

Official Title
-----------------
REDUCE Trial: The Effects of Perineural Dexamethasone on Scalp Nerve Blocks for Relief of Postcraniotomy Pain

Conditions
-----------------
Postoperative Pain, Craniotomy, Dexamethasone, Scalp Nerve Blocks

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Dexamethasone combined with bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for elective supratentorial craniotomy under general anesthesia; age 18 to 64 years; an American Society of Anesthesiologists (ASA) physical status of I, II or III; preoperative Glasgow Coma Scale (GCS) score of 15/15. Exclusion Criteria: History of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy; Inability to understand or use the pain scales before surgery; Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery; Request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery; Pregnancy or breastfeeding; Extreme body mass index (BMI) (< 15 or > 35); Participation in another interventional trial that interferes with the intervention or outcome of this trial; Refusal or inability of the patient and/or legal guardian to provide informed consent; Coagulopathy; Infection around the puncture point; History of allergies to any of the study drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000 | Drug: Bupivacaine<br>* The control group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus normal saline 1 ml. The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.<br>|
| Experimental: DEX4mg group<br>DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000. | Drug: Dexamethasone combined with bupivacaine<br>* The DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus 4 mg dexamethasone (1 ml). The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of analgesia | The time between the performance of the block and the administration of the first press the PCA demand button postoperatively. | Within 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sufentanil consumption | The cumulative amount of sufentanil consumption by PCA | At 4, 12, 24 and 48 hours postoperatively | 
| Numeric rating scale (NRS) | NRS: 11-point scale in which 0 = no pain to 10 = worst imaginable pain. An NRS score ≥4 will be considered significant or moderate pain. An NRS score ≥7 will be considered severe pain. Meanwhile, the localization of the site of the pain will also be documented. | At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively | 
| Glasgow Coma Scale (GCS) | A scale for measuring level of consciousness, in which scoring is determined by three factors: amount of eye opening, verbal responsiveness, and motor responsiveness. | At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively | 
| Postoperative nausea and vomiting (PONV) | Vomiting will be defined as the forceful expulsion of gastric contents, and nausea will be defined as an unpleasant sensation associated with the urge to vomit. | Within 48 hours after surgery | 
| Bradycardia | Bradycardia will be defined as HR<60 beats/minute in at least two instances more than 5 minutes apart. | Within 48 hours after surgery | 
| Hypotension | Hypotension will be defined as any of the following: systolic BP <90 mm Hg for 5 minutes or a 35% decrease in mean arterial blood pressure. | Within 48 hours after surgery | 
| Emergence delirium | Emergence delirium will be assessed by the Sedation Agitation Scale (SAS), a 7-point scale on which a higher score represents greater agitation. | Within 48 hours after surgery | 
| The length of stay (LOS) | The LOS will be defined as the number of nights spent in the hospital after surgery. | About at 2 weeks after surgery | 
| Patient satisfaction score (PSS) | PSS: 0 for unsatisfactory to 10 for very satisfactory. | At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively |