Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

• Sponsor: University of South Alabama (Other)
• Overall Status: Completed
• CT.gov ID: NCT01242644
• Collaborator: (none)
• Enrollment: 48
• Arms: 3
• Duration (Months): 44

Study Details

Study Description

Brief Summary

Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.

Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: pain pump containing ropivacaine; Device: saline pain pump with injectable medication; Drug: ropivacaine, ketorolac , morphine sulfate	Phase 2

Detailed Description

Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pain pump , injectable medication 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;	Device: pain pump containing ropivacaine; 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; Other Names: ropivacaine pain pump
Active Comparator: saline pain pump , injectable medication 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	Device: saline pain pump with injectable medication; 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; Other Names: ketorolac saline
Active Comparator: injectable medication only 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.	Drug: ropivacaine, ketorolac , morphine sulfate; 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected; Other Names: morphine sulfate

Outcome Measures

Primary Outcome Measures

1. Pain Score 8 Hours Post-operativley [8 hours post surgery]

   Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

2. Pain Scale [24 hours post surgery]

   Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

3. Pain Scale [48 hours post-surgery]

   Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

4. Pain Scale [72 hours post surgery]

   Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

Secondary Outcome Measures

1. Number of Narcotic Pills and Morphine Sulfate Used [In recovery room]

   Pill count

2. Number of Narcotic Pills and Morphine Sulfate Used [Post surgery day 1]

   Pill Count

3. Number of Narcotic Pills and Morphine Sulfate Used [Post surgery day 2]

4. Number of Narcotic Pills and Morphine Sulfate Used [Post surgery day 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: All subjects who underwent:

• knee arthroscopy + synovectomy

• knee arthroscopy + partial or complete meniscectomy

• knee arthroscopy + chondroplasty

• knee arthroscopy + microfracture

• knee arthroscopy + autologous osteoarticular transplantation

Exclusion Criteria:

• A surgical procedure that required an incision other then an arthroscopic portal

• A surgical procedure within the same joint within ninety days

• A acute or chronic knee infection

• Any diagnosis of complex regional pain syndrome

• A known allergy to one of the study drugs

• A documented history of narcotic use

• A score of less than two standard deviation on the SF-12 mental component

• Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)

• Under the age of eighteen years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of South Alabama

Investigators

• Principal Investigator: Albert W Pearsall, MD, University of South Alabama

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Alabama
• ClinicalTrials.gov Identifier: NCT01242644
• Other Study ID Numbers: 06-230
• First Posted: Nov 17, 2010
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Ketorolac; Ketorolac Tromethamine; Morphine; Ropivacaine

Study Results

Participant Flow

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Period Title: Overall Study
STARTED	16	17	15
COMPLETED	16	17	15
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only	Total
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected	Total of all reporting groups
Overall Participants	16	17	15	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (0.9)	51 (0.9)	49.9 (0.9)	51 (0.9)
Sex/Gender, Customized (participants) [Number]
Female	6 37.5%	10 58.8%	8 53.3%	24 50%
Male	10 62.5%	7 41.2%	7 46.7%	24 50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%	17 100%	15 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Pain Score 8 Hours Post-operativley
Description	Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame	8 hours post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [units on a scale]	2.5 (0.3282)	1.8 (0.3282)	1.06 (0.3282)

2. Primary Outcome

Title	Pain Scale
Description	Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame	24 hours post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [units on a scale]	1.75 (0.16)	3.23 (0.16)	3.06 (0.16)

3. Primary Outcome

Title	Pain Scale
Description	Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame	48 hours post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [units on a scale]	1.81 (0.14)	3.17 (0.14)	2.26 (0.14)

4. Primary Outcome

Title	Pain Scale
Description	Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Time Frame	72 hours post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [units on a scale]	3.3 (0.46)	4.05 (0.46)	3.13 (0.46)

5. Secondary Outcome

Title	Number of Narcotic Pills and Morphine Sulfate Used
Description	Pill count
Time Frame	In recovery room

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [Pills]	2.2 (0.61)	1.8 (0.61)	1.3 (0.61)

6. Secondary Outcome

Title	Number of Narcotic Pills and Morphine Sulfate Used
Description	Pill Count
Time Frame	Post surgery day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [Number of pills]	3.41 (0.87)	3.8 (0.87)	3.8 (0.87)

7. Secondary Outcome

Title	Number of Narcotic Pills and Morphine Sulfate Used
Time Frame	Post surgery day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [Number of pills]	1.1 (0.08)	1.5 (0.08)	0.8 (0.08)

8. Secondary Outcome

Title	Number of Narcotic Pills and Morphine Sulfate Used
Time Frame	Post surgery day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pain Pump , Injectable Medication	Saline Pain Pump , Injectable Medication	Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Measure Participants	16	17	15
Mean (Standard Deviation) [number of pills]	2.1 (0.16)	2.7 (0.16)	1.7 (0.16)

Adverse Events

Time Frame	At 12 months post-operatively
Arm/Group Title	Pain Pump , Injectable Medication		Saline Pain Pump , Injectable Medication		Injectable Medication Only
Arm/Group Description	30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; pain pump containing ropivacaine: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour		30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour saline pain pump with injectable medication: 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour		30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump. ropivacaine, ketorolac , morphine sulfate: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
All Cause Mortality
	Pain Pump , Injectable Medication		Saline Pain Pump , Injectable Medication		Injectable Medication Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)		0/15 (0%)
Serious Adverse Events
	Pain Pump , Injectable Medication		Saline Pain Pump , Injectable Medication		Injectable Medication Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Pain Pump , Injectable Medication		Saline Pain Pump , Injectable Medication		Injectable Medication Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/17 (0%)		0/15 (0%)

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.