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Completed

NCT Number: NCT01690663

Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

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.

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Key information

Conditions

Post Surgical Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19139, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Ability to sign informed consent.
  • Ability to follow study protocol, and speak, read and write in English.
  • Must have valid phone number for follow-up purpose.
  • Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.

Exclusion criteria

  • Patient younger than 18 years old and older than age 70
  • Patient refusal to sign consent
  • Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
  • Allergy to any of the protocol medications
  • 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
  • Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Treatment and study plan

Bupivacaine 0.25%

Drug

Dexamethasone

Drug

normal saline

Drug

placebo

Primary outcomes

  1. Primary Outcome Variable is Post Operative Sensory Block Duration

    Time frame: days 1, 2, and day 7

    This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.

Secondary outcomes

  1. The Secondary Outcome Variable is Post Operative Motor Block Duration

    Time frame: days 1, 2, and day 7

    This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block, a Randomized, Placebo Controlled Prospective Clinical Trial

Acronym: Dex Dose

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2012
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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