Trial Outcomes & Findings for ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management (NCT NCT00638508)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

67 participants

Primary outcome timeframe

1 hour after the surgery

Results posted on

2018-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Rpopivacaine Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% via an infusion catheter at the incision siteKetorolac and Ropivacaine
Overall Study STARTED	35	32
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketorolac Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Rpopivacaine Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% via an infusion catheter at the incision siteKetorolac and Ropivacaine
Overall Study Physician Decision	5	2

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site.	Total n=60 Participants Total of all reporting groups
Age, Continuous	25 years n=5 Participants • 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.	25 years n=7 Participants • 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.	25 years n=5 Participants • 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 Female	30 Participants n=5 Participants • 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.	30 Participants n=7 Participants • 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.	60 Participants n=5 Participants • 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 Male	0 Participants n=5 Participants • 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.	0 Participants n=7 Participants • 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.	0 Participants n=5 Participants • 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 United States	30 Participants n=5 Participants • 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.	30 Participants n=7 Participants • 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.	60 Participants n=5 Participants • 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	6.7 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants • 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.	6.2 units on a scale STANDARD_DEVIATION 2.9 • n=7 Participants • 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.	6.40 units on a scale STANDARD_DEVIATION 2.6 • n=5 Participants • 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	6.3 milligrams STANDARD_DEVIATION 1.9 • n=5 Participants • 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.	4.0 milligrams STANDARD_DEVIATION 2.9 • n=7 Participants • 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.	5.2 milligrams STANDARD_DEVIATION 2.8 • n=5 Participants • 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	27 years n=5 Participants • 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.	26 years n=7 Participants • 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.	27 years n=5 Participants • 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.

PRIMARY outcome

Timeframe: 1 hour after the surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Scores at Rest	6.7 units on a scale Standard Deviation 2.2	6.2 units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: At the end of 6 hours after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Score at Rest	3.6 units on a scale Standard Deviation 2.3	4.4 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 48 hours after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Scores at Rest	1.4 units on a scale Standard Deviation 1.6	1.6 units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 1 hour after the surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Score on Coughing	7.6 units on a scale Standard Deviation 2.2	7.5 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 6 hours after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Scores on Coughing	5.3 units on a scale Standard Deviation 2.5	6.2 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 48 hours after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Scores on Coughing	3.4 units on a scale Standard Deviation 2.7	2.8 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 1 hour after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain on Movement	7.7 units on a scale Standard Deviation 1.9	7.3 units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 6 hours after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain Scores on Movement	5.7 units on a scale Standard Deviation 2.3	26.2 units on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: 48 hours afetr surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Pain on Movement	3.1 units on a scale Standard Deviation 2.5	2.5 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1 hour after surgery

Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Morphine Equivalents Utilization	6.3 miliigrams Standard Deviation 1.9	4 miliigrams Standard Deviation 2.9

SECONDARY outcome

Timeframe: 12 hours after surgery

Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Morphine Equivalents	2.1 milligrams Standard Deviation 1.4	1.5 milligrams Standard Deviation 1.1

SECONDARY outcome

Timeframe: 48 hours afetr surgery

Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
Morphine Equivalents	4.2 milligrams Standard Deviation 2.5	4.6 milligrams Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1 hour after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
DROWSINESS	4 units on a scale Standard Deviation 2.7	4.4 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 48 hours

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
DROWSINESS	0.6 units on a scale Standard Deviation 1.7	0.1 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: 1 hour after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
NAUSEA	0.6 units on a scale Standard Deviation 1.6	0.9 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 48 hours

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
NAUSEA	0.3 units on a scale Standard Deviation 0.9	0.4 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 6 hours after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
VOMITING	0.2 EPISODES Standard Deviation 0.6	0.1 EPISODES Standard Deviation 0.3

SECONDARY outcome

Timeframe: 12 hours

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
VOMITING	0 EPISODES Standard Deviation 0	0 EPISODES Standard Deviation 0

SECONDARY outcome

Timeframe: 1 hour after surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
PATIENT SATISFACTION	5.4 units on a scale Standard Deviation 2.6	4.9 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 48 hours afetr surgery

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=30 Participants Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day	Ketorolac With Ropivacaine n=30 Participants Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site
PATIENT SATISFACTION	8.5 units on a scale Standard Deviation 1.4	8.5 units on a scale Standard Deviation 1.6

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketorolac and Ropivacainr

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kalpana Tyagaraj, M.D.

Maimonides Medical Center

Phone: 718-283-9162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place