Trial Outcomes & Findings for Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA) (NCT NCT01042093)

Results Overview

Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

2 days after surgery

Results posted on

2013-11-08

Participant Flow

All patients scheduled for Total Knee Replacement (TKR), by the investigator and considered suitable for participation,were recruited for the study from Jan 2010 through June 2011.

Before assignment to groups all participants were screened for certain exclusion criteria including; pregnant/lactating women, allergies/contraindications to study medications/spinal anesthesia, drug/alcohol abuse, psychologic disorder, diagnosis of inflammatory arthritis, previous major surgery to operative knee, and simultaneous bilateral TKR's.

Participant milestones

Participant milestones
Measure	ROP/EPI/TOR/CLO Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	REP/EPI/TOR Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)	REP/EPI/CLO Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	REP/EPI Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
Overall Study STARTED	40	40	40	40
Overall Study COMPLETED	38	38	38	36
Overall Study NOT COMPLETED	2	2	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	ROP/EPI/TOR/CLO Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	REP/EPI/TOR Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)	REP/EPI/CLO Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	REP/EPI Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
Overall Study Protocol Violation	2	2	2	3
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ROP/EPI/TOR/CLO n=40 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI/TOR n=40 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)	ROP/EPI/CLO n=40 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI n=40 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	11 Participants n=4 Participants	59 Participants n=21 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	21 Participants n=7 Participants	24 Participants n=5 Participants	29 Participants n=4 Participants	101 Participants n=21 Participants
Age Continuous	66.74 years STANDARD_DEVIATION 8.07 • n=5 Participants	66.29 years STANDARD_DEVIATION 8.20 • n=7 Participants	68.26 years STANDARD_DEVIATION 7.47 • n=5 Participants	69.25 years STANDARD_DEVIATION 8.67 • n=4 Participants	67.64 years STANDARD_DEVIATION 8.10 • n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	27 Participants n=4 Participants	98 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	13 Participants n=4 Participants	62 Participants n=21 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	40 participants n=5 Participants	40 participants n=4 Participants	160 participants n=21 Participants

PRIMARY outcome

Timeframe: 2 days after surgery

Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.

Outcome measures

Outcome measures
Measure	ROP/EPI/TOR/CLO n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI/TOR n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)	ROP/EPI/CLO n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI n=36 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 1 Hour Post Op	1.06 scores on a scale 0-10 Standard Deviation 1.74	1.90 scores on a scale 0-10 Standard Deviation 1.04	2.67 scores on a scale 0-10 Standard Deviation 3.06	1.60 scores on a scale 0-10 Standard Deviation 2.01
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 8 Hour Post Op	1.52 scores on a scale 0-10 Standard Deviation 1.54	1.52 scores on a scale 0-10 Standard Deviation 1.56	3.93 scores on a scale 0-10 Standard Deviation 2.57	2.82 scores on a scale 0-10 Standard Deviation 1.93
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 16 Hour Post Op	1.85 scores on a scale 0-10 Standard Deviation 1.69	2.22 scores on a scale 0-10 Standard Deviation 2.36	2.75 scores on a scale 0-10 Standard Deviation 2.36	2.41 scores on a scale 0-10 Standard Deviation 1.65
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 24 Hour Post Op	2.33 scores on a scale 0-10 Standard Deviation 2.06	2.56 scores on a scale 0-10 Standard Deviation 1.76	3.63 scores on a scale 0-10 Standard Deviation 2.86	2.96 scores on a scale 0-10 Standard Deviation 2.28
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 32 Hour Post Op	2.18 scores on a scale 0-10 Standard Deviation 2.13	2.66 scores on a scale 0-10 Standard Deviation 2.13	3.62 scores on a scale 0-10 Standard Deviation 2.19	3.13 scores on a scale 0-10 Standard Deviation 2.07
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 40 Hour Post Op	2.54 scores on a scale 0-10 Standard Deviation 2.20	2.35 scores on a scale 0-10 Standard Deviation 2.31	3.28 scores on a scale 0-10 Standard Deviation 2.49	2.80 scores on a scale 0-10 Standard Deviation 2.27
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale - 48 Hour Post Op	2.41 scores on a scale 0-10 Standard Deviation 2.25	1.97 scores on a scale 0-10 Standard Deviation 1.72	2.56 scores on a scale 0-10 Standard Deviation 2.20	2.11 scores on a scale 0-10 Standard Deviation 1.98
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. Vas Pain Scale Preoperatively	1.93 scores on a scale 0-10 Standard Deviation 2.07	2.47 scores on a scale 0-10 Standard Deviation 2.25	2.43 scores on a scale 0-10 Standard Deviation 2.40	2.13 scores on a scale 0-10 Standard Deviation 2.48

SECONDARY outcome

Timeframe: 4 days

A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.

Outcome measures

Outcome measures
Measure	ROP/EPI/TOR/CLO n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI/TOR n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)	ROP/EPI/CLO n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI n=36 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
Narcotic Consumption During Hospitalization Morphine Equivalent Day of Surgery	46.92 mg Standard Deviation 22.29	43.09 mg Standard Deviation 25.33	55.20 mg Standard Deviation 28.00	52.50 mg Standard Deviation 27.12
Narcotic Consumption During Hospitalization Morphine Equivalent Post Operative Day 1	46.54 mg Standard Deviation 29.14	47.95 mg Standard Deviation 35.89	64.61 mg Standard Deviation 41.71	51.08 mg Standard Deviation 39.98
Narcotic Consumption During Hospitalization Morphine Equivalent Post Operative Day 2	40.71 mg Standard Deviation 29.67	42.69 mg Standard Deviation 37.28	50.07 mg Standard Deviation 44.11	36.76 mg Standard Deviation 35.28
Narcotic Consumption During Hospitalization Morphine Equivalent Post Operative Day 3	20.45 mg Standard Deviation 19.88	18.72 mg Standard Deviation 20.73	21.97 mg Standard Deviation 22.38	15.54 mg Standard Deviation 21.77

SECONDARY outcome

Timeframe: 6 weeks after surgery

Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	ROP/EPI/TOR/CLO n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI/TOR n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)	ROP/EPI/CLO n=38 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)	ROP/EPI n=36 Participants Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
Knee Society Pain Scores at 6 Week Follow-up Appointment	45 Scores on a scale 0-50 Interval 30.0 to 50.0	43 Scores on a scale 0-50 Interval 10.0 to 50.0	45 Scores on a scale 0-50 Interval 10.0 to 50.0	45 Scores on a scale 0-50 Interval 10.0 to 50.0

Adverse Events

ROP/EPI/TOR/CLO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ROP/EPI/TOR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ROP/EPI/CLO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ROP/EPI

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

David F. Dalury, MD

Towson Orthopaedic Associates

Phone: 410-337-7900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place