Trial Outcomes & Findings for Liposomal Bupivacaine in Total Shoulder Arthroplasty (NCT NCT02570022)

NCT ID: NCT02570022

Last Updated: 2016-10-13

Results Overview

Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 57 participants
• Primary outcome timeframe: four days postoperatively
• Results posted on: 2016-10-13

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Liposomal bupivacaine: Local infiltration of liposomal bupivacaine	Inter-scalene Nerve Block Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. Inter-scalene nerve block: Pre-operative inter-scalene nerve block Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
Overall Study STARTED	26	31
Overall Study COMPLETED	26	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Bupivacaine in Total Shoulder Arthroplasty

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=26 Participants Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Liposomal bupivacaine: Local infiltration of liposomal bupivacaine	Inter-scalene Nerve Block n=31 Participants Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. Inter-scalene nerve block: Pre-operative inter-scalene nerve block Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.	Total n=57 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
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	27 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	69.4 years n=5 Participants	67.1 years n=7 Participants	67.8 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	31 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: four days postoperatively

Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.

Outcome measures

Measure	Liposomal Bupivacaine n=26 Participants Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Liposomal bupivacaine: Local infiltration of liposomal bupivacaine	Inter-scalene Nerve Block n=31 Participants Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. Inter-scalene nerve block: Pre-operative inter-scalene nerve block Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
Pain Levels Mean Pain score Day 0	4.8 units on a scale Standard Deviation 1.8	4.0 units on a scale Standard Deviation 1.8
Pain Levels Mean Pain score Day 1	4.7 units on a scale Standard Deviation 2.3	4.0 units on a scale Standard Deviation 1.7
Pain Levels Mean Pain score Day 2	4.3 units on a scale Standard Deviation 2.5	3.6 units on a scale Standard Deviation 1.7
Pain Levels Mean Pain score Day 3	4.1 units on a scale Standard Deviation 2.0	4.3 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: four days postoperatively

Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.

Outcome measures

Measure	Liposomal Bupivacaine n=26 Participants Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Liposomal bupivacaine: Local infiltration of liposomal bupivacaine	Inter-scalene Nerve Block n=31 Participants Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. Inter-scalene nerve block: Pre-operative inter-scalene nerve block Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
Morphine Equivalents Mean Morphine equivalents used Day 0	14.8 mg of morphine equivalent Standard Deviation 9.2	21.4 mg of morphine equivalent Standard Deviation 11.3
Morphine Equivalents Mean Morphine equivalents used Day 1	8.9 mg of morphine equivalent Standard Deviation 9.7	9.1 mg of morphine equivalent Standard Deviation 11.4
Morphine Equivalents Mean Morphine equivalents used Day 2	12.3 mg of morphine equivalent Standard Deviation 16.9	5.2 mg of morphine equivalent Standard Deviation 10.8
Morphine Equivalents Mean Morphine equivalents used Day 3	2.8 mg of morphine equivalent Standard Deviation 4.1	2.2 mg of morphine equivalent Standard Deviation 6.1

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inter-scalene Nerve Block

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liposomal Bupivacaine n=26 participants at risk Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Liposomal bupivacaine: Local infiltration of liposomal bupivacaine	Inter-scalene Nerve Block n=31 participants at risk Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine. Inter-scalene nerve block: Pre-operative inter-scalene nerve block Ropivacaine: Ropivicaine was used for the inter-scalene nerve block.
Nervous system disorders Phrenic nerve palsy	0.00% 0/26	3.2% 1/31 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kelechi Okoroha

Henry Ford Hospital

Phone: 8324239895

Email: krokoroha@gmail.com

Results disclosure agreements

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