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Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy

Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02688530
Acronym
SCB & IV Dex
Enrollment
140
Registered
2016-02-23
Start date
2016-05-31
Completion date
2017-11-19
Last updated
2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthroscopy, Pain

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.

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.

Interventions

DRUGIV Dexamethasone 4mg
DRUGIV Dexamethasone 6mg
DRUGIV Dexamethasone 8mg

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder ArthroscopyDay 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

MeasureTime frameDescription
Duration of Motor Block From the Supraclavicular BlockDay 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.
Blood Glucose LevelsDay of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administrationFingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.
Occurrence of Postoperative NeuropraxiaPost-Operative Day 21Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Occurrence of Postoperative Wound InfectionPost-Operative Day 21Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Average Daily Pain Scores at Rest and With MovementDay 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).
Worst Daily Pain Scores at Rest and With MovementDay 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).
Patient Satisfaction With Postoperative AnalgesiaPost-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).
Cumulative Daily Opioid UsageRecovery 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
0mg IV Dexamethasone
0mg IV Dexamethasone
35
4mg IV Dexamethasone
4mg IV Dexamethasone
34
6mg IV Dexamethasone
6mg IV Dexamethasone
33
8mg IV Dexamethasone
8mg IV Dexamethasone
35
Total137

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up0020
Overall StudyWithdrawal by Subject0100

Baseline characteristics

Characteristic0mg IV Dexamethasone4mg IV Dexamethasone6mg IV Dexamethasone8mg IV DexamethasoneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants7 Participants8 Participants3 Participants25 Participants
Age, Categorical
Between 18 and 65 years
28 Participants27 Participants25 Participants32 Participants112 Participants
Age, Continuous49 years
STANDARD_DEVIATION 16
50 years
STANDARD_DEVIATION 17
52 years
STANDARD_DEVIATION 15
49 years
STANDARD_DEVIATION 12
50 years
STANDARD_DEVIATION 15
Race/Ethnicity, Customized
Race
Asian
1 Participants0 Participants0 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Race
Black/African American
1 Participants1 Participants1 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Race
Unknown
0 Participants1 Participants0 Participants2 Participants3 Participants
Race/Ethnicity, Customized
Race
White
33 Participants32 Participants32 Participants32 Participants129 Participants
Region of Enrollment
United States
35 participants34 participants33 participants35 participants137 participants
Sex: Female, Male
Female
16 Participants6 Participants10 Participants10 Participants42 Participants
Sex: Female, Male
Male
19 Participants28 Participants23 Participants25 Participants95 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 340 / 330 / 35
other
Total, other adverse events
4 / 352 / 346 / 333 / 35
serious
Total, serious adverse events
0 / 350 / 340 / 330 / 35

Outcome results

Primary

Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy

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)

ArmMeasureValue (MEDIAN)
0mg IV DexamethasoneDuration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy17.4 Hours
4mg IV DexamethasoneDuration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy22.7 Hours
6mg IV DexamethasoneDuration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy20.2 Hours
8mg IV DexamethasoneDuration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy19.8 Hours
Secondary

Average Daily Pain Scores at Rest and With Movement

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)

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

ArmMeasureGroupValue (MEAN)Dispersion
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score at rest2.6 score on a scaleStandard Deviation 1.9
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score at rest0.4 score on a scaleStandard Deviation 1.1
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score at rest4.1 score on a scaleStandard Deviation 2.5
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score at rest2.9 score on a scaleStandard Deviation 2.1
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score at rest0.5 score on a scaleStandard Deviation 0.7
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score with Movement4.6 score on a scaleStandard Deviation 2.3
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score with Movement0.5 score on a scaleStandard Deviation 1.4
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score with Movement5.2 score on a scaleStandard Deviation 2.6
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score with Movement4.6 score on a scaleStandard Deviation 2.6
0mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score with Movement6 score on a scaleStandard Deviation 2.8
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score at rest3.2 score on a scaleStandard Deviation 2.1
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score with Movement5.1 score on a scaleStandard Deviation 2.3
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score at rest3.7 score on a scaleStandard Deviation 1.8
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score at rest4 score on a scaleStandard Deviation 1.7
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score with Movement4.8 score on a scaleStandard Deviation 2.3
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score with Movement0.3 score on a scaleStandard Deviation 0.8
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score with Movement5 score on a scaleStandard Deviation 3
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score with Movement4.7 score on a scaleStandard Deviation 2.2
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score at rest3 score on a scaleStandard Deviation 2.5
4mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score at rest0.2 score on a scaleStandard Deviation 0.7
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score with Movement4.8 score on a scaleStandard Deviation 3.1
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score with Movement0.2 score on a scaleStandard Deviation 0.5
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score with Movement6 score on a scaleStandard Deviation 0
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score at rest2.4 score on a scaleStandard Deviation 2.4
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score at rest3.3 score on a scaleStandard Deviation 2.7
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score with Movement4.6 score on a scaleStandard Deviation 2.4
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score with Movement5 score on a scaleStandard Deviation 2.3
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score at rest0.4 score on a scaleStandard Deviation 0.9
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score at rest3 score on a scaleStandard Deviation 0
6mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score at rest3.1 score on a scaleStandard Deviation 2.8
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score at rest2 score on a scaleStandard Deviation 2
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score with Movement4.2 score on a scaleStandard Deviation 3.3
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score with Movement4.7 score on a scaleStandard Deviation 2.7
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD3 Average Pain Score with Movement1.7 score on a scaleStandard Deviation 1.5
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score with Movement0.4 score on a scaleStandard Deviation 1.7
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD0 Average Pain Score at rest0.5 score on a scaleStandard Deviation 1.6
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD1 Average Pain Score at rest3 score on a scaleStandard Deviation 2.5
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score at rest3.1 score on a scaleStandard Deviation 2.4
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPre-Op Average Pain Score at rest2.5 score on a scaleStandard Deviation 2.5
8mg IV DexamethasoneAverage Daily Pain Scores at Rest and With MovementPOD2 Average Pain Score with Movement4.8 score on a scaleStandard Deviation 2.3
Secondary

Blood Glucose Levels

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

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

ArmMeasureGroupValue (MEDIAN)Dispersion
0mg IV DexamethasoneBlood Glucose LevelsPrior to IV Dexamethasone102 mg/dLStandard Deviation 15
0mg IV DexamethasoneBlood Glucose Levels2 hours after IV Dexamethasone102 mg/dLStandard Deviation 20
0mg IV DexamethasoneBlood Glucose Levels1 hour after IV Dexamethasone119 mg/dLStandard Deviation 14
4mg IV DexamethasoneBlood Glucose LevelsPrior to IV Dexamethasone108 mg/dLStandard Deviation 14
4mg IV DexamethasoneBlood Glucose Levels2 hours after IV Dexamethasone125 mg/dLStandard Deviation 31
4mg IV DexamethasoneBlood Glucose Levels1 hour after IV Dexamethasone122 mg/dLStandard Deviation 17
6mg IV DexamethasoneBlood Glucose Levels1 hour after IV Dexamethasone119 mg/dLStandard Deviation 18
6mg IV DexamethasoneBlood Glucose LevelsPrior to IV Dexamethasone104 mg/dLStandard Deviation 16
6mg IV DexamethasoneBlood Glucose Levels2 hours after IV Dexamethasone110 mg/dLStandard Deviation 23
8mg IV DexamethasoneBlood Glucose LevelsPrior to IV Dexamethasone105 mg/dLStandard Deviation 18
8mg IV DexamethasoneBlood Glucose Levels2 hours after IV Dexamethasone110 mg/dLStandard Deviation 27
8mg IV DexamethasoneBlood Glucose Levels1 hour after IV Dexamethasone126 mg/dLStandard Deviation 18
Secondary

Cumulative Daily Opioid Usage

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)

Population: Cumulative Daily Opioid Usage

ArmMeasureGroupValue (MEAN)Dispersion
0mg IV DexamethasoneCumulative Daily Opioid UsagePOD 1 (0-24hrs)31 oral morphine equivalent units (mg)Standard Deviation 23.7
0mg IV DexamethasoneCumulative Daily Opioid UsagePOD2 (24-48hrs)22.3 oral morphine equivalent units (mg)Standard Deviation 28.2
4mg IV DexamethasoneCumulative Daily Opioid UsagePOD2 (24-48hrs)27.4 oral morphine equivalent units (mg)Standard Deviation 41.4
4mg IV DexamethasoneCumulative Daily Opioid UsagePOD 1 (0-24hrs)30.5 oral morphine equivalent units (mg)Standard Deviation 29.3
6mg IV DexamethasoneCumulative Daily Opioid UsagePOD 1 (0-24hrs)30.7 oral morphine equivalent units (mg)Standard Deviation 25.9
6mg IV DexamethasoneCumulative Daily Opioid UsagePOD2 (24-48hrs)32.6 oral morphine equivalent units (mg)Standard Deviation 29.3
8mg IV DexamethasoneCumulative Daily Opioid UsagePOD 1 (0-24hrs)31.3 oral morphine equivalent units (mg)Standard Deviation 34.1
8mg IV DexamethasoneCumulative Daily Opioid UsagePOD2 (24-48hrs)36.5 oral morphine equivalent units (mg)Standard Deviation 47.5
Secondary

Duration of Motor Block From the Supraclavicular Block

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)

Population: shoulder arthroscopy

ArmMeasureValue (MEDIAN)
0mg IV DexamethasoneDuration of Motor Block From the Supraclavicular Block10.5 Hours
4mg IV DexamethasoneDuration of Motor Block From the Supraclavicular Block19.7 Hours
6mg IV DexamethasoneDuration of Motor Block From the Supraclavicular Block18.3 Hours
8mg IV DexamethasoneDuration of Motor Block From the Supraclavicular Block14.7 Hours
Secondary

Occurrence of Postoperative Neuropraxia

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
0mg IV DexamethasoneOccurrence of Postoperative Neuropraxia0 Participants
4mg IV DexamethasoneOccurrence of Postoperative Neuropraxia1 Participants
6mg IV DexamethasoneOccurrence of Postoperative Neuropraxia0 Participants
8mg IV DexamethasoneOccurrence of Postoperative Neuropraxia0 Participants
Secondary

Occurrence of Postoperative Wound Infection

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
0mg IV DexamethasoneOccurrence of Postoperative Wound Infection0 Participants
4mg IV DexamethasoneOccurrence of Postoperative Wound Infection0 Participants
6mg IV DexamethasoneOccurrence of Postoperative Wound Infection0 Participants
8mg IV DexamethasoneOccurrence of Postoperative Wound Infection0 Participants
Secondary

Patient Satisfaction With Postoperative Analgesia

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)

Population: Patient Satisfaction with Post-Op Analgesia

ArmMeasureValue (MEAN)Dispersion
0mg IV DexamethasonePatient Satisfaction With Postoperative Analgesia9.1 score on a scaleStandard Deviation 1.2
4mg IV DexamethasonePatient Satisfaction With Postoperative Analgesia8.9 score on a scaleStandard Deviation 1.6
6mg IV DexamethasonePatient Satisfaction With Postoperative Analgesia9.2 score on a scaleStandard Deviation 1.2
8mg IV DexamethasonePatient Satisfaction With Postoperative Analgesia8.7 score on a scaleStandard Deviation 1.7
Secondary

Worst Daily Pain Scores at Rest and With Movement

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)

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

ArmMeasureGroupValue (MEAN)Dispersion
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score with Movement0.6 score on a scaleStandard Deviation 1.9
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score at rest2 score on a scaleStandard Deviation 1.4
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score at rest6.3 score on a scaleStandard Deviation 2.9
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score with Movement6.1 score on a scaleStandard Deviation 2.7
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score at rest0.6 score on a scaleStandard Deviation 1.5
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score with Movement7 score on a scaleStandard Deviation 1.4
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score with Movement6.5 score on a scaleStandard Deviation 2.9
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score at rest4.7 score on a scaleStandard Deviation 3
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score at rest3.4 score on a scaleStandard Deviation 2.1
0mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score with Movement7.3 score on a scaleStandard Deviation 2.6
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score with Movement0.3 score on a scaleStandard Deviation 0.8
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score at rest4.6 score on a scaleStandard Deviation 2.8
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score at rest5.4 score on a scaleStandard Deviation 2.3
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score at rest6.3 score on a scaleStandard Deviation 2.9
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score with Movement6.5 score on a scaleStandard Deviation 2.4
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score at rest0.2 score on a scaleStandard Deviation 0.7
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score with Movement5.9 score on a scaleStandard Deviation 2.7
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score with Movement6.8 score on a scaleStandard Deviation 2.2
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score with Movement6.7 score on a scaleStandard Deviation 3.2
4mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score at rest3.3 score on a scaleStandard Deviation 2.9
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score at rest0.5 score on a scaleStandard Deviation 1.3
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score at rest5.4 score on a scaleStandard Deviation 3.2
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score with Movement6.5 score on a scaleStandard Deviation 3.1
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score with Movement7 score on a scaleStandard Deviation 0
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score with Movement0.3 score on a scaleStandard Deviation 0.8
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score at rest5 score on a scaleStandard Deviation 0
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score at rest5.1 score on a scaleStandard Deviation 2.8
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score with Movement6.4 score on a scaleStandard Deviation 2.5
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score at rest3.4 score on a scaleStandard Deviation 2.6
6mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score with Movement6.7 score on a scaleStandard Deviation 2.2
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score at rest4.5 score on a scaleStandard Deviation 3.3
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score with Movement1.2 score on a scaleStandard Deviation 3.3
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score with Movement5.7 score on a scaleStandard Deviation 3.4
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD1 Worst Pain Score at rest5.1 score on a scaleStandard Deviation 3.5
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD2 Worst Pain Score with Movement6.3 score on a scaleStandard Deviation 2.5
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score at rest3.6 score on a scaleStandard Deviation 3.1
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score at rest4.3 score on a scaleStandard Deviation 3.5
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD3 Worst Pain Score with Movement3.7 score on a scaleStandard Deviation 3.2
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPre-Op Worst Pain Score with Movement6.9 score on a scaleStandard Deviation 2.7
8mg IV DexamethasoneWorst Daily Pain Scores at Rest and With MovementPOD0 Worst Pain Score at rest1.1 score on a scaleStandard Deviation 2.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026