Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% (Dex Dose)

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University of Pennsylvania

Status

Completed

Conditions

Post Surgical Pain

Treatments

Drug: Bupivacaine 0.25%
Drug: normal saline
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT01690663
815628

Details and patient eligibility

About

When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.

Full description

The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.

Enrollment

89 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
  2. Ability to sign informed consent.
  3. Ability to follow study protocol, and speak, read and write in English.
  4. Must have valid phone number for follow-up purpose.
  5. Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.

Exclusion criteria

  1. Patient younger than 18 years old and older than age 70
  2. Patient refusal to sign consent
  3. Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
  4. Allergy to any of the protocol medications
  5. Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
  6. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

89 participants in 4 patient groups, including a placebo group

Bupivacaine 0.25% mixed with 1ml normal saline
Placebo Comparator group
Description:
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Treatment:
Drug: normal saline
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% with 1mg dexamethasone (1ml)
Active Comparator group
Description:
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Treatment:
Drug: Dexamethasone
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% mixed with 2mg dexamethasone
Active Comparator group
Description:
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Treatment:
Drug: Dexamethasone
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
Active Comparator group
Description:
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Treatment:
Drug: Dexamethasone
Drug: Bupivacaine 0.25%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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