Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

• ClinicalTrials.gov Identifier: NCT01149616
• Recruitment Status: Terminated
• First Posted: June 23, 2010
• Results First Posted: July 7, 2017
• Last Update Posted: July 7, 2017
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Lauren J. Fisher, Beth Israel Deaconess Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Post Operative Pain; Nausea
• Interventions: Drug: Dexamethasone 8mg iv x1; Drug: placebo
• Enrollment: 82

Participant Flow

Recruitment Details	2010
Pre-assignment Details

Arm/Group Title	Intervention	Placebo
Arm/Group Description	Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	placebo placebo: placebo administered IV x1
Period Title: Overall Study
Started	41	41
Completed	41	41
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Intervention	Placebo	Total
Arm/Group Description		Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	placebo placebo: placebo administered IV x1	Total of all reporting groups
Overall Number of Baseline Participants		41	41	82
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	41 participants	82 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	41 100.0%	41 100.0%	82 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	41 participants	82 participants
	Female	15 36.6%	16 39.0%	31 37.8%
	Male	26 63.4%	25 61.0%	51 62.2%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	41 participants	41 participants	82 participants
		41	41	82

Outcome Measures

1. Primary Outcome

Title	Post Operative VAS Pain Scale
Description	Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description:	Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	placebo placebo: placebo administered IV x1
Overall Number of Participants Analyzed	41	41
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.88 (0.3)	3.73 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

2. Secondary Outcome

Title	Amount of Postop Narcotic Usage
Description	Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description:	Dexamethasone 8mg iv x 1	placebo: 2 ml normal saline IV x1
Overall Number of Participants Analyzed	41	41
Median (Inter-Quartile Range); Unit of Measure: number of tablets
	1; (1 to 2)	2; (2 to 4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

3. Secondary Outcome

Title	Postop Nausea
Description	NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description:	Dexamethasone 8mg iv x 1	placebo: 2 ml normal saline IV x1
Overall Number of Participants Analyzed	41	41
Mean (Inter-Quartile Range); Unit of Measure: units on a scale
	0; (0 to 0)	0; (0 to 1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.05
	Comments	P value was calculated, and threshold for significance calculated at less than or equal to 0.05
	Method	ANOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Intervention	Placebo
Arm/Group Description	Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	placebo placebo: placebo administered 2 ml normal saline IV x1
All-Cause Mortality
	Intervention	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/41 (0.00%)
Serious Adverse Events
	Intervention	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/41 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Intervention	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/41 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.

Results Point of Contact

• Name/Title: Dr Lauren Fisher
• Organization: Beth Israel Deaconess Medical Center
• Phone: 6176671853
• EMail: lauren_fisher@dmgaz.org

• Responsible Party: Lauren J. Fisher, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT01149616
• Other Study ID Numbers: 2009P000345
• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Results First Submitted: March 1, 2017
• Results First Posted: July 7, 2017
• Last Update Posted: July 7, 2017