Trial Outcomes & Findings for Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty (NCT NCT02570503)

Results Overview

Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

3 days after surgery

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	ROP/KET/CLON/EPI/SAL Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml	Placebo 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
Overall Study STARTED	34	30
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ROP/KET/CLON/EPI/SAL n=34 Participants Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml	Placebo n=30 Participants 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml	Total n=64 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 8.1 • n=34 Participants	64.1 years STANDARD_DEVIATION 9.4 • n=30 Participants	64.6 years STANDARD_DEVIATION 8.6 • n=64 Participants
Sex: Female, Male Female	15 Participants n=34 Participants	16 Participants n=30 Participants	31 Participants n=64 Participants
Sex: Female, Male Male	19 Participants n=34 Participants	14 Participants n=30 Participants	33 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	34 participants n=34 Participants	30 participants n=30 Participants	64 participants n=64 Participants

PRIMARY outcome

Timeframe: 3 days after surgery

Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported

Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period

The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.

Outcome measures

Outcome measures
Measure	ROP/KET/CLON/EPI/SAL n=34 Participants Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Ropivacaine: Ropivacaine (5mg/ml)-50ml Ketorolac: ketorolac (30mg/ml)- 1 ml Clonidine: clonidine (0.1mg/ml)- 0.8ml Epinephrine: epinephrine (1mg/ml)-1ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml	Placebo n=30 Participants 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml
Narcotic Use During Hospitalization 0 to 24 hour post surgery period	58.9 mg morphine equivalents Standard Deviation 41.2	72.3 mg morphine equivalents Standard Deviation 49.4
Narcotic Use During Hospitalization 24 to 48 hour post surgery period	66.5 mg morphine equivalents Standard Deviation 51.3	72.8 mg morphine equivalents Standard Deviation 61.7
Narcotic Use During Hospitalization Full 48 hour post surgery period	125.6 mg morphine equivalents Standard Deviation 80.7	145.7 mg morphine equivalents Standard Deviation 99.2

SECONDARY outcome

Timeframe: 3 days after surgery

Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported

Patients are asked if their pain is acceptable (yes/no)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days after surgery

Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported

Pain in score change after physical therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours after surgery

Population: Protocol was amended early in the study to omit this outcome due to apparent data irregularities - no data was collected and no outcomes can be reported

The length (in feet) patient is able to ambulate during physical therapy

Outcome measures

Outcome data not reported

Adverse Events

ROP/KET/CLON/EPI/SAL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Teresa Potter

Virginia Commonwealth University

Phone: 804-828-6749

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place