Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    108
  • sponsor
    Ohio State University
Updated on 28 October 2021

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.

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.

Details
Condition Hand Surgery
Treatment Dexamethasone
Clinical Study IdentifierNCT03512223
SponsorOhio State University
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note