Trial Outcomes & Findings for Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA) (NCT NCT02197273)

NCT ID: NCT02197273

Last Updated: 2016-10-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 211 participants
• Primary outcome timeframe: Participants were followed for the duration of hospital stay, an expected average of 3 days
• Results posted on: 2016-10-21

Participant Flow

Recruitment period July 1, 2014 to September 30, 2015 for patients undergoing total hip, knee or shoulder arthroplasty at OhioHealth Riverside Methodist Hospital.

Patients were randomized in a one to one fashion to one of two study groups within each surgical group. 10 patients were excluded after enrollment due to dual enrollment in another study, changes in anesthesia plan or improper dose of study drug. These 10 patients were not included in the analysis.

Participant milestones

Measure	Standard of Care Analgesia THA: 33 patients received a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TKA: 39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TSA: 35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Standard of care analgesia	Liposomal Bupivacaine THA: 36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: 34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: 34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Liposomal bupivacaine Standard of care analgesia
Overall Study STARTED	107	104
Overall Study COMPLETED	107	104
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)

Baseline characteristics by cohort

Measure	Standard of Care Analgesia n=107 Participants THA: All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TKA: All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TSA: All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Standard of care analgesia	Liposomal Bupivacaine n=104 Participants THA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Liposomal bupivacaine Standard of care analgesia	Total n=211 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 8.4 • n=5 Participants	65.9 years STANDARD_DEVIATION 9.1 • n=7 Participants	66.3 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	43 Participants n=7 Participants	93 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Measure	Standard of Care Analgesia n=107 Participants THA: 33 patients received a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TKA: 39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TSA: 35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Standard of care analgesia	Liposomal Bupivacaine n=104 Participants THA: 36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: 34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: 34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Liposomal bupivacaine Standard of care analgesia
Length of Stay in Hospital (Days)	2.0 days Interval 1.0 to 7.0	2.0 days Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days

Outcome measures

Measure	Standard of Care Analgesia n=107 Participants THA: 33 patients received a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TKA: 39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TSA: 35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Standard of care analgesia	Liposomal Bupivacaine n=104 Participants THA: 36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: 34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: 34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Liposomal bupivacaine Standard of care analgesia
Time to Post-operative Rescue Opioids (Hours)	7.7 hours Interval 2.6 to 49.5	11.8 hours Interval 2.2 to 75.0

SECONDARY outcome

Timeframe: Date of discharge through 30 days following discharge

Outcome measures

Measure	Standard of Care Analgesia n=107 Participants THA: 33 patients received a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TKA: 39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TSA: 35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Standard of care analgesia	Liposomal Bupivacaine n=104 Participants THA: 36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: 34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: 34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Liposomal bupivacaine Standard of care analgesia
Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days	2 participants	4 participants

Adverse Events

Standard of Care Analgesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard of Care Analgesia n=107 participants at risk THA: 33 patients received a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TKA: 39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline TSA: 35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Standard of care analgesia	Liposomal Bupivacaine n=104 participants at risk THA: 36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: 33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: 34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Liposomal bupivacaine Standard of care analgesia
Musculoskeletal and connective tissue disorders knee pain	0.00% 0/107	1.9% 2/104 • Number of events 2

Additional Information

Deborah Napier

OhioHealth

Phone: 614-566-5575

Email: Deborah.Napier@ohiohealth.com

Results disclosure agreements

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