Clinical trial
REDUCE Trial: The Effects of Perineural Dexamethasone on Scalp Nerve Blocks for Relief of Postcraniotomy Pain
Name
KY 2018-034-02-9
Description
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.
Trial arms
Trial start
2020-12-13
Estimated PCD
2023-01-02
Trial end
2023-01-02
Status
Completed
Treatment
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.
Arms:
Control group
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.
Arms:
DEX4mg group
Size
156
Primary endpoint
The duration of analgesia
Within 48 hours after surgery
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 156, 'type': 'ACTUAL'}}
Updated at
2024-01-25
1 organization
2 products
4 indications
Organization
Beijing Tiantan HospitalProduct
BupivacaineIndication
Postoperative PainIndication
CraniotomyIndication
DexamethasoneIndication
Scalp Nerve BlocksProduct
Dexamethasone + Bupivacaine