SCB & IV Dex: Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT02688530
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 4
• Duration (Months): 18.6
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Arthroscopy; Pain	Drug: IV Saline; Drug: IV Dexamethasone 4mg; Drug: IV Dexamethasone 6mg; Drug: IV Dexamethasone 8mg	Phase 4

Detailed Description

Numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. However, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. Moreover, recent studies suggest that high dose IV dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. However these studies only utilized fixed, high level doses of IV dexamethasone. Moreover, there remains a concern that high dose IV dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. Open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not IV dexamethasone causes greater increase. To the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of IV dexamethasone. The investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of IV dexamethasone. The investigators also seek to identify what association, if any, is noted between IV dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. Finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of IV dexamethasone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Nov 19, 2017
• Actual Study Completion Date: Nov 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 0mg IV Dexamethasone 0mg IV Dexamethasone	Drug: IV Saline
Experimental: 4mg IV Dexamethasone 4mg IV Dexamethasone	Drug: IV Dexamethasone 4mg
Experimental: 6mg IV Dexamethasone 6mg IV Dexamethasone	Drug: IV Dexamethasone 6mg
Experimental: 8mg IV Dexamethasone 8mg IV Dexamethasone	Drug: IV Dexamethasone 8mg

Outcome Measures

Primary Outcome Measures

1. Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy [Day of Surgery until Post-Operative Day 3 (if the block persists)]

   Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.

Secondary Outcome Measures

1. Duration of Motor Block From the Supraclavicular Block [Day of Surgery until Post-Operative Day 3 (if the block persists)]

   Defined as the time from block placement to restoration of normal strength at both the wrist and elbow.

2. Blood Glucose Levels [Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration]

   Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.

3. Occurrence of Postoperative Neuropraxia [Post-Operative Day 21]

   Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.

4. Occurrence of Postoperative Wound Infection [Post-Operative Day 21]

   Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.

5. Average Daily Pain Scores at Rest and With Movement [Day of Surgery until Post-Operative Day 3 (if the block persists)]

   Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).

6. Worst Daily Pain Scores at Rest and With Movement [Day of Surgery until Post-Operative Day 3 (if the block persists)]

   Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).

7. Patient Satisfaction With Postoperative Analgesia [Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)]

   Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best).

8. Cumulative Daily Opioid Usage [Recovery Room until Post-Operative Day 3 (if block persists)]

   Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients undergoing shoulder arthroscopy under regional anesthesia

Exclusion Criteria:

• General anesthesia

• Contraindication to regional anesthesia

• Pre-existing neuropathy in the surgical limb

• Diabetes Mellitus

• History of postoperative nausea and vomiting &/ or motion sickness

• Procedures involving biceps tenotomy

• Peri-articular cocktail injections given intraoperatively to augment pain relief

• Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks)

• Open surgical procedures

• Corticosteroid injection within 1 month

• Patients on systemic oral or IV steroid therapy within 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 29, 2016

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT02688530
• Other Study ID Numbers: 2015-853
• First Posted: Feb 23, 2016
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Additional relevant MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

Participant Flow

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Period Title: Overall Study
STARTED	35	35	35	35
COMPLETED	35	34	33	35
NOT COMPLETED	0	1	2	0

Baseline Characteristics

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone	Total
Arm/Group Description	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone	Total of all reporting groups
Overall Participants	35	34	33	35	137
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	28 80%	27 79.4%	25 75.8%	32 91.4%	112 81.8%
>=65 years	7 20%	7 20.6%	8 24.2%	3 8.6%	25 18.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49 (16)	50 (17)	52 (15)	49 (12)	50 (15)
Sex: Female, Male (Count of Participants)
Female	16 45.7%	6 17.6%	10 30.3%	10 28.6%	42 30.7%
Male	19 54.3%	28 82.4%	23 69.7%	25 71.4%	95 69.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 2.9%	0 0%	0 0%	1 2.9%	2 1.5%
Black/African American	1 2.9%	1 2.9%	1 3%	0 0%	3 2.2%
White	33 94.3%	32 94.1%	32 97%	32 91.4%	129 94.2%
Unknown	0 0%	1 2.9%	0 0%	2 5.7%	3 2.2%
Region of Enrollment (participants) [Number]
United States	35 100%	34 100%	33 100%	35 100%	137 100%

Outcome Measures

1. Primary Outcome

Title	Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
Description	Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
Time Frame	Day of Surgery until Post-Operative Day 3 (if the block persists)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Measure Participants	35	34	33	35
Median (95% Confidence Interval) [Hours]	17.4	22.7	20.2	19.8

2. Secondary Outcome

Title	Duration of Motor Block From the Supraclavicular Block
Description	Defined as the time from block placement to restoration of normal strength at both the wrist and elbow.
Time Frame	Day of Surgery until Post-Operative Day 3 (if the block persists)

Outcome Measure Data

Analysis Population Description

shoulder arthroscopy

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Measure Participants	35	34	33	35
Median (95% Confidence Interval) [Hours]	10.5	19.7	18.3	14.7

3. Secondary Outcome

Title	Blood Glucose Levels
Description	Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.
Time Frame	Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration

Outcome Measure Data

Analysis Population Description

Prior to IV Dexamethasone, 1-hour and 2-hours after IV Dexamethasone administration

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	35	34	31	33
Prior to IV Dexamethasone	102 (15)	108 (14)	104 (16)	105 (18)
1 hour after IV Dexamethasone	119 (14)	122 (17)	119 (18)	126 (18)
2 hours after IV Dexamethasone	102 (20)	125 (31)	110 (23)	110 (27)

4. Secondary Outcome

Title	Occurrence of Postoperative Neuropraxia
Description	Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Time Frame	Post-Operative Day 21

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	28	29	27	28
Count of Participants [Participants]	0 0%	1 2.9%	0 0%	0 0%

5. Secondary Outcome

Title	Occurrence of Postoperative Wound Infection
Description	Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Time Frame	Post-Operative Day 21

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	28	29	27	28
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Average Daily Pain Scores at Rest and With Movement
Description	Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Time Frame	Day of Surgery until Post-Operative Day 3 (if the block persists)

Outcome Measure Data

Analysis Population Description

Average daily pain scores Pre-Op to POD3 at rest and with movement.

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	35	34	33	35
Pre-Op Average Pain Score at rest	2.6 (1.9)	3 (2.5)	2.4 (2.4)	2.5 (2.5)
POD0 Average Pain Score at rest	0.4 (1.1)	0.2 (0.7)	0.4 (0.9)	0.5 (1.6)
POD1 Average Pain Score at rest	4.1 (2.5)	3.2 (2.1)	3.1 (2.8)	3 (2.5)
POD2 Average Pain Score at rest	2.9 (2.1)	3.7 (1.8)	3.3 (2.7)	3.1 (2.4)
POD3 Average Pain Score at rest	0.5 (0.7)	4 (1.7)	3 (0)	2 (2)
Pre-Op Average Pain Score with Movement	4.6 (2.3)	4.8 (2.3)	4.6 (2.4)	4.7 (2.7)
POD0 Average Pain Score with Movement	0.5 (1.4)	0.3 (0.8)	0.2 (0.5)	0.4 (1.7)
POD1 Average Pain Score with Movement	5.2 (2.6)	4.7 (2.2)	4.8 (3.1)	4.2 (3.3)
POD2 Average Pain Score with Movement	4.6 (2.6)	5.1 (2.3)	5 (2.3)	4.8 (2.3)
POD3 Average Pain Score with Movement	6 (2.8)	5 (3)	6 (0)	1.7 (1.5)

7. Secondary Outcome

Title	Worst Daily Pain Scores at Rest and With Movement
Description	Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Time Frame	Day of Surgery until Post-Operative Day 3 (if the block persists)

Outcome Measure Data

Analysis Population Description

Worst Daily Pain Scores at rest and with movement from Pre-Op to POD3

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	35	34	33	35
Pre-Op Worst Pain Score at rest	3.4 (2.1)	3.3 (2.9)	3.4 (2.6)	3.6 (3.1)
POD0 Worst Pain Score at rest	0.6 (1.5)	0.2 (0.7)	0.5 (1.3)	1.1 (2.7)
POD1 Worst Pain Score at rest	6.3 (2.9)	4.6 (2.8)	5.4 (3.2)	5.1 (3.5)
POD2 Worst Pain Score at rest	4.7 (3)	5.4 (2.3)	5.1 (2.8)	4.5 (3.3)
POD3 Worst Pain Score at rest	2 (1.4)	6.3 (2.9)	5 (0)	4.3 (3.5)
Pre-Op Worst Pain Score with Movement	6.1 (2.7)	6.5 (2.4)	6.4 (2.5)	6.9 (2.7)
POD0 Worst Pain Score with Movement	0.6 (1.9)	0.3 (0.8)	0.3 (0.8)	1.2 (3.3)
POD1 Worst Pain Score with Movement	7.3 (2.6)	5.9 (2.7)	6.5 (3.1)	5.7 (3.4)
POD2 Worst Pain Score with Movement	6.5 (2.9)	6.8 (2.2)	6.7 (2.2)	6.3 (2.5)
POD3 Worst Pain Score with Movement	7 (1.4)	6.7 (3.2)	7 (0)	3.7 (3.2)

8. Secondary Outcome

Title	Patient Satisfaction With Postoperative Analgesia
Description	Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best).
Time Frame	Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)

Outcome Measure Data

Analysis Population Description

Patient Satisfaction with Post-Op Analgesia

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	28	29	27	28
Mean (Standard Deviation) [score on a scale]	9.1 (1.2)	8.9 (1.6)	9.2 (1.2)	8.7 (1.7)

9. Secondary Outcome

Title	Cumulative Daily Opioid Usage
Description	Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview.
Time Frame	Recovery Room until Post-Operative Day 3 (if block persists)

Outcome Measure Data

Analysis Population Description

Cumulative Daily Opioid Usage

Arm/Group Title	0mg IV Dexamethasone	4mg IV Dexamethasone	6mg IV Dexamethasone	8mg IV Dexamethasone
Arm/Group Description	0mg IV Dexamethasone IV Saline	4mg IV Dexamethasone IV Dexamethasone 4mg	6mg IV Dexamethasone IV Dexamethasone 6mg	8mg IV Dexamethasone IV Dexamethasone 8mg
Measure Participants	35	34	33	35
POD 1 (0-24hrs)	31 (23.7)	30.5 (29.3)	30.7 (25.9)	31.3 (34.1)
POD2 (24-48hrs)	22.3 (28.2)	27.4 (41.4)	32.6 (29.3)	36.5 (47.5)

Adverse Events

Time Frame	These protocol deviations were between 4/7/17-10/9/2017. Patients were followed for 3 days after surgery.
Arm/Group Title	0mg IV Dexamethasone		4mg IV Dexamethasone		6mg IV Dexamethasone		8mg IV Dexamethasone
Arm/Group Description	0 mg IV Dexamethasone Adverse Event		4 mg IV Dexamethasone Adverse Event		6 mg IV Dexamethasone Adverse Event		8 mg IV Dexamethasone Adverse Event
All Cause Mortality
	0mg IV Dexamethasone		4mg IV Dexamethasone		6mg IV Dexamethasone		8mg IV Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)		0/33 (0%)		0/35 (0%)
Serious Adverse Events
	0mg IV Dexamethasone		4mg IV Dexamethasone		6mg IV Dexamethasone		8mg IV Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)		0/33 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	0mg IV Dexamethasone		4mg IV Dexamethasone		6mg IV Dexamethasone		8mg IV Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/35 (11.4%)		2/34 (5.9%)		6/33 (18.2%)		3/35 (8.6%)
Surgical and medical procedures
Protocol Deviation	4/35 (11.4%)	4	2/34 (5.9%)	2	6/33 (18.2%)	6	3/35 (8.6%)	3

Limitations/Caveats

[Not Specified]

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.