Trial Outcomes & Findings for Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade (NCT NCT01335542)

Last Updated: 2022-04-14

Results Overview

The primary outcome is time until a patient is "ready for discharge." Discharge criteria are: * PCA (if present) has been discontinued * Not experiencing moderate or severe nausea (within last 4 hours). * Solid food diet * Able to urinate (Foley catheter removed) * Pain: NRS \<4. * Surgical wound dry * No acute medical problems * Physical Therapy Criteria * Independently transfer from supine to sit, from sitting to standing * Ambulate 40 ft. without assistance * Extension range of motion (\< 10 degrees)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

91 participants

Primary outcome timeframe

Participants will be followed for the duration of their hospital stay, an expected average of 3 days

Results posted on

2022-04-14

Participant Flow

One patient in the local infiltration group was deemed ineligible due to a rheumatoid arthritis. Only 90 patients were randomized to the study.

Participant milestones

Participant milestones
Measure	Epidural Pathway meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV	Local Infiltration meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural Pathway n=45 Participants meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV	Local Infiltration n=45 Participants meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)	Total n=90 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	65 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
BMI Normal	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
BMI Overweight	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants
BMI Obese	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants
BMI Morbidly Obese	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 3 days

Outcome measures

Outcome measures
Measure	Epidural Pathway n=45 Participants meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV	Local Infiltration n=45 Participants meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
The Primary Outcome is Time Until a Patient is "Ready for Discharge."	3.2 days Interval 1.8 to 7.0	3.2 days Interval 1.0 to 14.0

Adverse Events

Epidural Pathway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Local Infiltration

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

Dr. Jacques YaDeau

Hospital for Special Surgery

Phone: 2127742224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place