Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
Study Details
Study Description
Brief Summary
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
Data Collection:
Data will be collected from the patient's medical record after discharge
Variables include:
-
Age
-
Sex
-
BMI
-
UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
-
Patient's assessment of acceptability of pain
-
UPAT score as assessed by physical therapy pre and post therapy sessions
-
Duramorph dose
-
Time patient arrived on the Orthopedic Unit
-
Length of ambulation during physical therapy sessions
-
Amount of supplementary opioids (measured in morphine equivalents)
-
Use of anti-emetics
-
Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
-
Length of hospital stay
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: Ropivacaine
Ropivacaine (5mg/ml)-50ml
Other Names:
Drug: Ketorolac
ketorolac (30mg/ml)- 1 ml
Other Names:
Drug: Clonidine
clonidine (0.1mg/ml)- 0.8ml
Other Names:
Drug: Epinephrine
epinephrine (1mg/ml)-1ml
Other Names:
Drug: 0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Other Names:
|
Placebo Comparator: Placebo 0.9% Sodium Chloride- 100ml |
Drug: 0.9% sodium chloride
Sodium chloride 0.9%- 47.7 ml
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Universal Pain Assessment Tool (UPAT) [3 days after surgery]
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.
- Narcotic Use During Hospitalization [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.
Secondary Outcome Measures
- Patient's Subjective Rating of Pain [3 days after surgery]
Patients are asked if their pain is acceptable (yes/no)
- UPAT Score Before and After Physical Therapy [3 days after surgery]
Pain in score change after physical therapy
- Ambulation During Physical Therapy [48 hours after surgery]
The length (in feet) patient is able to ambulate during physical therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
-
Written informed consent
Exclusion Criteria:
-
Pregnant women
-
Creatinine clearance less than 60 ml/min
-
BMI greater than 40
-
Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
-
Receive a unicondylar knee replacement
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Gregory Golladay, MD, Virginia Commonwealth University
Study Documents (Full-Text)
More Information
Publications
None provided.- HM20004125
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo |
---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
Period Title: Overall Study | ||
STARTED | 34 | 30 |
COMPLETED | 34 | 30 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo | Total |
---|---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | Total of all reporting groups |
Overall Participants | 34 | 30 | 64 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
65.0
(8.1)
|
64.1
(9.4)
|
64.6
(8.6)
|
Sex: Female, Male (Count of Participants) | |||
Female |
15
44.1%
|
16
53.3%
|
31
48.4%
|
Male |
19
55.9%
|
14
46.7%
|
33
51.6%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (participants) [Number] | |||
United States |
34
100%
|
30
100%
|
64
100%
|
Outcome Measures
Title | Universal Pain Assessment Tool (UPAT) |
---|---|
Description | 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. |
Time Frame | 3 days after surgery |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo |
---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
Measure Participants | 0 | 0 |
Title | Narcotic Use During Hospitalization |
---|---|
Description | 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. |
Time Frame | 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo |
---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
Measure Participants | 34 | 30 |
0 to 24 hour post surgery period |
58.9
(41.2)
|
72.3
(49.4)
|
24 to 48 hour post surgery period |
66.5
(51.3)
|
72.8
(61.7)
|
Full 48 hour post surgery period |
125.6
(80.7)
|
145.7
(99.2)
|
Title | Patient's Subjective Rating of Pain |
---|---|
Description | Patients are asked if their pain is acceptable (yes/no) |
Time Frame | 3 days after surgery |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo |
---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
Measure Participants | 0 | 0 |
Title | UPAT Score Before and After Physical Therapy |
---|---|
Description | Pain in score change after physical therapy |
Time Frame | 3 days after surgery |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo |
---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
Measure Participants | 0 | 0 |
Title | Ambulation During Physical Therapy |
---|---|
Description | The length (in feet) patient is able to ambulate during physical therapy |
Time Frame | 48 hours after surgery |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo |
---|---|---|
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | 48 hours post surgery | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | ROP/KET/CLON/EPI/SAL | Placebo | ||
Arm/Group Description | 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 | 0.9% Sodium Chloride- 100ml 0.9% sodium chloride: Sodium chloride 0.9%- 47.7 ml | ||
All Cause Mortality |
||||
ROP/KET/CLON/EPI/SAL | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/30 (0%) | ||
Serious Adverse Events |
||||
ROP/KET/CLON/EPI/SAL | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/30 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
ROP/KET/CLON/EPI/SAL | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/34 (0%) | 0/30 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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
Name/Title | Teresa Potter |
---|---|
Organization | Virginia Commonwealth University |
Phone | 804-828-6749 |
teresa.potter@vcuhealth.org |
- HM20004125