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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01690663
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arms: 4
• Duration (Months): 29
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Surgical Pain	Drug: Bupivacaine 0.25%; Drug: Dexamethasone; Drug: normal saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19139

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Jiabin Liu, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01690663
• Other Study ID Numbers: 815628
• First Posted: Sep 24, 2012
• Last Update Posted: May 4, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	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/Group Description	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo	Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone
Period Title: Overall Study
STARTED	23	20	22	24
COMPLETED	20	17	19	20
NOT COMPLETED	3	3	3	4

Baseline Characteristics

Arm/Group Title	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	Total
Arm/Group Description	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo	Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone	Total of all reporting groups
Overall Participants	23	20	22	24	89
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	23 100%	20 100%	22 100%	24 100%	89 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.1 (11.3)	46.2 (11.8)	48.8 (14.1)	53.0 (12.5)	48.4 (12.4)
Sex: Female, Male (Count of Participants)
Female	5 21.7%	6 30%	6 27.3%	5 20.8%	22 24.7%
Male	18 78.3%	14 70%	16 72.7%	19 79.2%	67 75.3%
Region of Enrollment (participants) [Number]
United States	23 100%	20 100%	22 100%	24 100%	89 100%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.4 (6.6)	29.4 (4.0)	28.9 (4.4)	31.0 (6.3)	30.3 (5.7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	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/Group Description	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo	Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone
Measure Participants	20	17	19	20
Mean (Inter-Quartile Range) [hours]	12.1	22.3	23.3	21.2

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	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/Group Description	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo	Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone	Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone
Measure Participants	20	17	19	20
Mean (Inter-Quartile Range) [hours]	12.1	21	20.9	19.4

Adverse Events

Arm/Group Title	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/Group Description	Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo		Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone		Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone		Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone
All Cause Mortality
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)		0/22 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)		0/22 (0%)		0/24 (0%)

Limitations/Caveats

First, all information was collected via telephone call during the recovery period at home, during which recall may be inaccurate. Second, we did not control the intravenous dexamethasone use, which could potentially affect the analgesia duration.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.