Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/27/2019 |
Start Date: | October 23, 2018 |
End Date: | March 31, 2021 |
Contact: | Alberto Uribe |
Email: | alberto.uribe@osumc.edu |
Phone: | 6142933559 |
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.
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.
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.
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.
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
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Michael Kushelev, MD
Phone: 614-293-3559
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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