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

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01149616
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain; Nausea	Drug: Dexamethasone 8mg iv x1; Drug: placebo	Phase 4

Detailed Description

Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Dexamethasone 8mg iv x 1	Drug: Dexamethasone 8mg iv x1; Dexamethasone 8mg iv x1
Placebo Comparator: Placebo placebo	Drug: placebo; 2 ml normal saline IV x1

Outcome Measures

Primary Outcome Measures

1. Post Operative VAS Pain Scale [24 hours]

   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.

Secondary Outcome Measures

1. Amount of Postop Narcotic Usage [24 hours]

   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

2. Postop Nausea [24 hours]

   NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult patients undergoing ambulatory knee arthroscopy surgery

• Must provide phone contact number and agree to phone followup on post operative day 1

Exclusion Criteria:

• Patients with major systemic disease

• Allergy or intolerance to study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Lauren Fisher, DO, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lauren J. Fisher, Attending Physician, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT01149616
• Other Study ID Numbers: 2009P000345
• First Posted: Jun 23, 2010
• Last Update Posted: Jul 7, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone

Study Results

Participant Flow

Recruitment Details	2010

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 Participants	41	41	82
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	41 100%	82 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	15 36.6%	16 39%	31 37.8%
Male	26 63.4%	25 61%	51 62.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	41 100%	41 100%	82 100%

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
Measure Participants	41	41
Mean (Standard Deviation) [units on a scale]	1.88 (0.3)	3.73 (0.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANOVA
	Comments

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
Measure Participants	41	41
Median (Inter-Quartile Range) [number of tablets]	1	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANOVA
	Comments

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
Measure Participants	41	41
Mean (Inter-Quartile Range) [units on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
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

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Serious Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)

Limitations/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.