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ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management

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ClinicalTrials.gov Identifier: NCT00638508
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
kalpana tyagaraj, Maimonides Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Ketorolac
Drug: Ketorolac and Ropivacaine
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketorolac Ketorolac With Rpopivacaine
Hide Arm/Group Description Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% via an infusion catheter at the incision siteKetorolac and Ropivacaine
Period Title: Overall Study
Started 35 32
Completed 30 30
Not Completed 5 2
Reason Not Completed
Physician Decision             5             2
Arm/Group Title Ketorolac Ketorolac With Ropivacaine Total
Hide Arm/Group Description Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group. Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study. Reason for omission- Physician decision.
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
25
(18 to 45)
25
(18 to 45)
25
(18 to 45)
[1]
Measure Analysis Population Description:

Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.

Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.

Reason for omission- Physician decision.

Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
30
 100.0%
30
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description:

Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.

Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.

Reason for omission- Physician decision.

Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
[1]
Measure Analysis Population Description:

Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.

Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.

Reason for omission- Physician decision.

Pain score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
6.7  (2.2) 6.2  (2.9) 6.40  (2.6)
[1]
Measure Description: Patients report pain scores using Visual Analog Scale (VAS) . This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
[2]
Measure Analysis Population Description:

Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.

Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.

Reason for omission- Physician decision.

Rescue analgesia utilization   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Milligrams
Number Analyzed 30 participants 30 participants 60 participants
6.3  (1.9) 4.0  (2.9) 5.2  (2.8)
[1]
Measure Description: Data is obtained regarding use of additional pain medications for breakthrough pain like morphine and acetaminophen with codeine. Rescue analgesics are converted to morphine equivalents and reported in milligrams.
[2]
Measure Analysis Population Description:

Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.

Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.

Reason for omission- Physician decision.

Age   [1] [2] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
27
(18 to 45)
26
(18 to 45)
27
(18 to 45)
[1]
Measure Description: Age of the participating patients, reported in years.
[2]
Measure Analysis Population Description:

Overall number of participants: 35 in Ketorolac group and 32 in Ketorolac with Ropivacaine group.

Number of participants analyzed: 30 in each group. 5 participants from the ketorolac and 2 participants from the Ketorolac with Ropivacaine group were omitted from the study.

Reason for omission- Physician decision.

1.Primary Outcome
Title Pain Scores at Rest
Hide Description Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 1 hour after the surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.7  (2.2) 6.2  (2.9)
2.Primary Outcome
Title Pain Score at Rest
Hide Description Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame At the end of 6 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.6  (2.3) 4.4  (2.5)
3.Primary Outcome
Title Pain Scores at Rest
Hide Description Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 48 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:

Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day

Ketorolac: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day

Patients will receive Ketorolac 5 mg/hour and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (1.6) 1.6  (2.1)
4.Primary Outcome
Title Pain Score on Coughing
Hide Description Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 1 hour after the surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.6  (2.2) 7.5  (2.5)
5.Primary Outcome
Title Pain Scores on Coughing
Hide Description Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 6 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (2.5) 6.2  (2.4)
6.Primary Outcome
Title Pain Scores on Coughing
Hide Description Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 48 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (2.7) 2.8  (2.3)
7.Primary Outcome
Title Pain on Movement
Hide Description Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.7  (1.9) 7.3  (2.9)
8.Primary Outcome
Title Pain Scores on Movement
Hide Description Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 6 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.7  (2.3) 26.2  (2.7)
9.Primary Outcome
Title Pain on Movement
Hide Description Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.
Time Frame 48 hours afetr surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.1  (2.5) 2.5  (1.9)
10.Secondary Outcome
Title Morphine Equivalents Utilization
Hide Description Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams.
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: miliigrams
6.3  (1.9) 4  (2.9)
11.Secondary Outcome
Title Morphine Equivalents
Hide Description Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams.
Time Frame 12 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: milligrams
2.1  (1.4) 1.5  (1.1)
12.Secondary Outcome
Title Morphine Equivalents
Hide Description Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams.
Time Frame 48 hours afetr surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: milligrams
4.2  (2.5) 4.6  (1.9)
13.Secondary Outcome
Title DROWSINESS
Hide Description The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally drowsy and "10" meaning maximally drowsy.
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
4  (2.7) 4.4  (2.7)
14.Secondary Outcome
Title DROWSINESS
Hide Description The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally drowsy and "10" meaning maximally drowsy.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.7) 0.1  (0.4)
15.Secondary Outcome
Title NAUSEA
Hide Description The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally nauseous and "10" meaning maximally nauseous.
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.6) 0.9  (2.0)
16.Secondary Outcome
Title NAUSEA
Hide Description The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, "1" meaning minimally nauseous and "10" meaning maximally nauseous.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.3  (0.9) 0.4  (1.8)
17.Secondary Outcome
Title VOMITING
Hide Description Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.
Time Frame 6 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: EPISODES
0.2  (0.6) 0.1  (0.3)
18.Secondary Outcome
Title VOMITING
Hide Description Data on number of episodes of vomiting was obtained, 12 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: EPISODES
0  (0) 0  (0)
19.Secondary Outcome
Title PATIENT SATISFACTION
Hide Description Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, "1" indicating least satisfied and "10" indication very well satisfied.
Time Frame 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.4  (2.6) 4.9  (2.8)
20.Secondary Outcome
Title PATIENT SATISFACTION
Hide Description Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, "1" indicating least satisfied and "10" indication very well satisfied.
Time Frame 48 hours afetr surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ketorolac With Ropivacaine
Hide Arm/Group Description:
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.5  (1.4) 8.5  (1.6)
Time Frame one year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Ketorolac and Ropivacainr
Hide Arm/Group Description Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site.
All-Cause Mortality
Ketorolac Ketorolac and Ropivacainr
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Ketorolac and Ropivacainr
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketorolac Ketorolac and Ropivacainr
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Kalpana Tyagaraj, M.D.
Organization: Maimonides Medical Center
Phone: 718-283-9162
EMail: Kalpana_tyagaraj@msn.com
Layout table for additonal information
Responsible Party: kalpana tyagaraj, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00638508     History of Changes
Other Study ID Numbers: 06/07/VA3
First Submitted: March 12, 2008
First Posted: March 19, 2008
Results First Submitted: August 17, 2011
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018