REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648358
• Other study ID #: KY 2018-034-02-9
• Status: Completed
• Phase: N/A
• Start date: December 13, 2020
• Est. completion date: January 2, 2023

Study information

• Verified date: January 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Craniotomy
• Dexamethasone
• Pain, Postoperative
• Postoperative Pain
• Scalp Nerve Blocks

Intervention

Drug:
• Bupivacaine
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.
• Dexamethasone combined with bupivacaine
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sufentanil consumption	The cumulative amount of sufentanil consumption by PCA	At 4, 12, 24 and 48 hours postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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