Trial Outcomes & Findings for A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty (NCT NCT00868348)

NCT ID: NCT00868348

Last Updated: 2014-03-10

Results Overview

Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 48 hours after surgery
• Results posted on: 2014-03-10

Participant Flow

A total of 361 patients were assessed for eligibility from May 2009 through March 2011; 62 patients participated in another study, 54 patients declined to participate, and 185 patients were excluded based on the exclusion criteria. Sixty patients (30 in each group)were enrolled, and data for the primary endpoint were registered in all patients

Participant milestones

Measure	Control Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

Baseline characteristics by cohort

Measure	Control n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants	8 Participants n=4 Participants	19 Participants n=27 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants	22 Participants n=4 Participants	41 Participants n=27 Participants
Age, Continuous	71 years n=93 Participants	70 years n=4 Participants	71 years n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	13 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	17 Participants n=4 Participants	28 Participants n=27 Participants
Region of Enrollment Denmark	30 participants n=93 Participants	30 participants n=4 Participants	60 participants n=27 Participants

PRIMARY outcome

Timeframe: 48 hours after surgery

Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery

Outcome measures

Measure	Control n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Morphine Consumption	48.75 mg Interval 30.0 to 82.2	10 mg Interval 0.0 to 22.5

SECONDARY outcome

Timeframe: within 48 hours after surgery

Outcome measures

Measure	Control n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request	223 min Interval 115.0 to 319.0	490 min Interval 248.0 to 617.0

SECONDARY outcome

Timeframe: 6-24 hours postoperatively

Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

Outcome measures

Measure	Control n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Pain Intensity Scores During Walking	64 mm Interval 51.0 to 80.0	29 mm Interval 5.0 to 47.0

SECONDARY outcome

Timeframe: time to fulfilment of discharge criteria

Ability to meet discharge criteria (home readiness)

Outcome measures

Measure	Control n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Home Readiness	3 days Interval 2.0 to 3.0	2 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: From the day of surgery until discharge

Outcome measures

Measure	Control n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Length of Hospital Stay	3 days Interval 3.0 to 3.0	3 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 16 weeks after surgery

Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

Outcome measures

Measure	Control n=28 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=29 Participants Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Pain Intensity During Daily Activity	4 mm Interval 1.0 to 21.0	3 mm Interval 3.0 to 12.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketorolac

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=30 participants at risk Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline	Ketorolac n=30 participants at risk Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
Blood and lymphatic system disorders Haematoma	0.00% 0/30	3.3% 1/30 • Number of events 1
Cardiac disorders tachycardia	0.00% 0/30	3.3% 1/30 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Karen V Andersen

Aarhus University Hospital

Phone: 51263173

Email: karenand@rm.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place