Back to resultsDose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% (Dex Dose)
Primary Purpose
Post Surgical Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine 0.25%
Dexamethasone
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Post Surgical Pain
Eligibility Criteria
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)
Sites / Locations
- Penn Presbyterian Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Bupivacaine 0.25% mixed with 1ml normal saline
Bupivacaine 0.25% with 1mg dexamethasone (1ml)
Bupivacaine 0.25% mixed with 2mg dexamethasone
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
Arm Description
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Outcomes
Primary Outcome Measures
Primary Outcome Variable is Post Operative Sensory Block Duration
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
The Secondary Outcome Variable is Post Operative Motor Block Duration
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.
Full Information
NCT ID
NCT01690663
First Posted
September 12, 2012
Last Updated
March 23, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01690663
Brief Title
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
Acronym
Dex Dose
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine 0.25% mixed with 1ml normal saline
Arm Type
Placebo Comparator
Arm Description
Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
Arm Title
Bupivacaine 0.25% with 1mg dexamethasone (1ml)
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Arm Title
Bupivacaine 0.25% mixed with 2mg dexamethasone
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
Arm Title
Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Primary Outcome Variable is Post Operative Sensory Block Duration
Description
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.
Time Frame
days 1, 2, and day 7
Secondary Outcome Measure Information:
Title
The Secondary Outcome Variable is Post Operative Motor Block Duration
Description
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.
Time Frame
days 1, 2, and day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiabin Liu, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%
We'll reach out to this number within 24 hrs