Clinical trial NCT03512223: Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery
Official title: Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hand Surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the if the administration of dexamethasone both around the nerve and in the vein (perineural and intravenous (IV)) will prolong the duration of pain relief from ropivacaine when compared with ropivacaine local block alone or when administered along with IV dexamethasone in patients undergoing hand surgery.

Detailed description: This study aims to evaluate the if the administration of dexamethasone both around the nerve and in the vein (perineural and intravenous (IV)) will prolong the duration of pain relief from ropivacaine when compared with ropivacaine local block alone or when administered along with IV dexamethasone in patients undergoing hand surgery. Individuals who have hand surgery scheduled will be evaluated for eligibility in this study. Eligible and consenting patients will be randomly assigned to one of three groups (1:1:1) as follows: • Group A (IV dexamethasone): Perineural (30ml of 0.75% ropivacaine + 0.5 ml normal saline) and IV (9.0 ml normal saline + 1 ml of 10 mg/ml Dexamethasone) • Group B (IV + perineural dexamethasone): Perineural (30ml of 0.75% ropivacaine + 0.5 ml of 10 mg/ml Dexamethasone) and IV (9.5 ml normal saline + 0.5 ml of 10 mg/ml Dexamethasone) • Group C (control with no adjuvant dexamethasone): Perineural (30ml of 0.75 ropivacaine + 0.5 ml normal saline) and IV (10 ml normal saline) This study is single-blind, so the subjects will not know to which group they have been assigned. All subjects will receive at least a nerve block with a local anesthetic, or numbing agent. After written, informed consent is obtained and on the day of surgery, the research staff will collect information about the subject's medical history including allergies (seasonal and drug related), demographics (gender, age, height, weight), history of drug use, pain and nausea scores, and vital signs. All medication taken 1 month prior to treatment day will be recorded. Information will be collected from the physical examination performed by the surgeon, which is a standard procedure for the pre-operative visit, regardless of participation in the study. After being put under light sedation according to standardized sedation, as written in the protocol, one group will receive a local nerve block and numbing agent. The other two groups will receive either the nerve block and local anesthetic with intravenous dexamethasone or the nerve block and local anesthetic with both intravenous and perineural (local) dexamethasone, as described above. Details regarding the subject's surgery and anesthesia will be collected, and after your surgery, a member of the research team will provide the subject with a diary to document level of pain, movement, any episodes of nausea/vomiting, and the number of pain medicine tablets taken for up to 48 hours after surgery. The subjects will receive a follow up phone call 48 hours after the nerve block from the research team to collect the information already documented in the diary. Thus far, no evidence of dexamethasone toxicity around the nerve has been shown and no neurologic complications or infections have been reported. Only one study reported blood glucose elevations \[1\]. There is a potential benefit of enhancing the duration of the nerve block and therefore pain management. The results of this study will help clarify if use of dexamethasone as an adjuvant in nerve block will prolong the effect of the nerve block and reduce the heightened sensitivity to pain and burning sensation as the block wears off.

Eligibility criteria: Inclusion Criteria:

* Adult male and female patients age 18-80
* Undergoing distal radius ORIF (open reduction internal fixation) or CMC (Carpometacarpal) arthroplasty
* ASA (American Society of Anesthesiologists) I, II,III
* Patients who provide a signed written informed consent
* Have a valid phone number and be able to speak, read, and write in English

Exclusion Criteria:

* Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
* Diabetes Mellitus
* Vulnerable populations: pregnant females, prisoners, breast feeding
* Contraindication to nerve block: local infections, bleeding disorders, shoulder deformity, allergy to local anesthetic or dexamethasone
* Severe lung disease, known contralateral phrenic nerve injury
* Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
* Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
* BMI ≥ 40 kg/m2

Primary outcomes:
measure: Duration of anesthetic blockade
timeFrame: 48 hours
Secondary outcomes:
measure: Duration of motor block
timeFrame: 48 hours
measure: Patient satisfaction on a scale of 0-10 (0=not satisfied at all 10=very satisfied) of pain management
timeFrame: 48 hours
measure: 48-hour postoperative units of oral morphine consumption
timeFrame: 48 hours
measure: the incidence of nausea and/or vomiting within 48 hour of the block
timeFrame: 48 hours
measure: • Rebound pain on a scale of 0-10 (0=no pain 10=worst possible pain), which is the worst level of pain experienced within the 2 hours after the block wore off
timeFrame: 48 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Assistant Professor-Clinical
name: Michael Kushelev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.