Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

Not Applicable

Completed

• Conditions: Post Surgical Pain
• Interventions: Drug: Bupivacaine 0.25%; Drug: Dexamethasone; Drug: normal saline

• Registration Number: NCT01690663
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-24
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-10-21
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Results First Posted: 2017-05-04
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine 0.25% mixed with 1ml normal saline	Bupivacaine 0.25%	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml	Dexamethasone	Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25% mixed with 2mg dexamethasone	Bupivacaine 0.25%	Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25% mixed with 1ml normal saline	normal saline	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml	Bupivacaine 0.25%	Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Bupivacaine 0.25% with 1mg dexamethasone (1ml)	Bupivacaine 0.25%	Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25% with 1mg dexamethasone (1ml)	Dexamethasone	Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25% mixed with 2mg dexamethasone	Dexamethasone	Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)

Primary Outcome Measures

Name	Time	Method
Primary Outcome Variable is Post Operative Sensory Block Duration	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 Outcome Measures

Name	Time	Method
The Secondary Outcome Variable is Post Operative Motor Block Duration	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.

Trial Locations

Locations (1)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States