REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

NCT04648358 | Completed DMC

• 1 other identifier: KY 2018-034-02-9
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Craniotomy; Dexamethasone; Scalp Nerve Blocks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Sufentanil consumption

  At 4, 12, 24 and 48 hours postoperatively

• Numeric rating scale (NRS)

  At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively

• Glasgow Coma Scale (GCS)

  At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively

• Postoperative nausea and vomiting (PONV)

  Within 48 hours after surgery

• Bradycardia

  Within 48 hours after surgery

Study Arms (2)

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

Drug: Bupivacaine

DEX4mg group

EXPERIMENTAL

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

Interventions

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.

Control group

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.

DEX4mg group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (7)

• 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.

  PMID: 20717011 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.

  PMID: 27164511 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.

  PMID: 8942596 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.

  PMID: 32054899 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.

  PMID: 27504384 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.

  PMID: 26756502 BACKGROUND

• 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.

  PMID: 34736497 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 1, 2020
• Study Start: December 13, 2020
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)