Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | The control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000 |
|
| DEX4mg group | Experimental | DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20717011 | Background | Flexman AM, Ng JL, Gelb AW. Acute and chronic pain following craniotomy. Curr Opin Anaesthesiol. 2010 Oct;23(5):551-7. doi: 10.1097/ACO.0b013e32833e15b9. | |
| 27164511 | Background | Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dexamethasone combined with bupivacaine | Drug | 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. |
|
| 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 |
| 8942596 | Background | Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022. |
| 32054899 | Background | Yang Y, Ou M, Zhou H, Tan L, Hu Y, Li Y, Zhu T. Effect of Scalp Nerve Block with Ropivacaine on Postoperative Pain in Patients Undergoing Craniotomy: A Randomized, Double Blinded Study. Sci Rep. 2020 Feb 13;10(1):2529. doi: 10.1038/s41598-020-59370-z. |
| 27504384 | Background | Baloda R, Bhupal JP, Kumar P, Gandhi GS. Supraclavicular Brachial Plexus Block With or Without Dexamethasone as an Adjuvant to 0.5% Levobupivacaine: A Comparative Study. J Clin Diagn Res. 2016 Jun;10(6):UC09-12. doi: 10.7860/JCDR/2016/18325.8048. Epub 2016 Jun 1. |
| 26756502 | Background | Jose R, Chakravarthy K, Nair S, Joseph M, Jeyaseelan V, Korula G. A Randomized Controlled Trial Studying the Role of Dexamethasone in Scalp Nerve Blocks for Supratentorial Craniotomy. J Neurosurg Anesthesiol. 2017 Apr;29(2):150-156. doi: 10.1097/ANA.0000000000000272. |
| 34736497 | Derived | Zhao C, Jia Z, Shrestha N, Luo F. REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain-a study protocol for a randomized controlled trial. Trials. 2021 Nov 4;22(1):772. doi: 10.1186/s13063-021-05747-y. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |