Trial Outcomes & Findings for Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty (NCT NCT02876055)
NCT ID: NCT02876055
Last Updated: 2019-04-16
Results Overview
The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
Post-Operative Day 1
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Single Shot Interscalene Nerve Block
An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.
Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
|
Continuous Interscalene Nerve Block
An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the post-anesthesia care unit (PACU) with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.
Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
|
Local Infiltration Analgesia (LIA)
The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.
Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
42
|
|
Overall Study
COMPLETED
|
42
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Shot Interscalene Nerve Block
n=42 Participants
An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.
Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
|
Continuous Interscalene Nerve Block
n=41 Participants
An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.
Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
|
Local Infiltration Analgesia (LIA)
n=42 Participants
The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.
Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 13.1 • n=42 Participants
|
68.1 years
STANDARD_DEVIATION 10.1 • n=41 Participants
|
69.5 years
STANDARD_DEVIATION 8.9 • n=42 Participants
|
68.4 years
STANDARD_DEVIATION 10.7 • n=125 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=42 Participants
|
22 Participants
n=41 Participants
|
17 Participants
n=42 Participants
|
61 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=42 Participants
|
19 Participants
n=41 Participants
|
25 Participants
n=42 Participants
|
64 Participants
n=125 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
42 participants
n=42 Participants
|
41 participants
n=41 Participants
|
42 participants
n=42 Participants
|
125 participants
n=125 Participants
|
|
Body Mass Index
|
30.3 kg/m^2
STANDARD_DEVIATION 5.2 • n=42 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=41 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 5.0 • n=42 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 5.3 • n=125 Participants
|
|
American Society of Anesthesiologists (ASA) Status
ASA I/II
|
28 Participants
n=42 Participants
|
26 Participants
n=41 Participants
|
27 Participants
n=42 Participants
|
81 Participants
n=125 Participants
|
|
American Society of Anesthesiologists (ASA) Status
ASA III
|
14 Participants
n=42 Participants
|
15 Participants
n=41 Participants
|
15 Participants
n=42 Participants
|
44 Participants
n=125 Participants
|
PRIMARY outcome
Timeframe: Post-Operative Day 1The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.
Outcome measures
| Measure |
Single Shot Interscalene Nerve Block
n=42 Participants
An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.
Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
|
Continuous Interscalene Nerve Block
n=41 Participants
An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.
Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
|
Local Infiltration Analgesia (LIA)
n=42 Participants
The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.
Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
|
|---|---|---|---|
|
Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).
|
2 score on a scale
Interval 1.0 to 4.0
|
0 score on a scale
Interval 0.0 to 2.0
|
3 score on a scale
Interval 2.0 to 4.0
|
Adverse Events
Single Shot Interscalene Nerve Block
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Continuous Interscalene Nerve Block
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Local Infiltration Analgesia (LIA)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Shot Interscalene Nerve Block
n=42 participants at risk
An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.
Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
|
Continuous Interscalene Nerve Block
n=41 participants at risk
An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.
Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
|
Local Infiltration Analgesia (LIA)
n=42 participants at risk
The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.
Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
|
|---|---|---|---|
|
General disorders
ICU admission
|
0.00%
0/42 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
0.00%
0/41 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
Other adverse events
| Measure |
Single Shot Interscalene Nerve Block
n=42 participants at risk
An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.
Single shot interscalene nerve block: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
|
Continuous Interscalene Nerve Block
n=41 participants at risk
An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the PACU with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.
Continuous interscalene nerve block: Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
|
Local Infiltration Analgesia (LIA)
n=42 participants at risk
The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.
Local Infiltration Analgesia (LIA): Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
|
|---|---|---|---|
|
Nervous system disorders
Neurapraxia
|
0.00%
0/42 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
4.9%
2/41 • Number of events 2 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
0.00%
0/42 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
|
General disorders
Fall
|
0.00%
0/42 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
0.00%
0/41 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspenea
|
2.4%
1/42 • Number of events 1 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
2.4%
1/41 • Number of events 1 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
0.00%
0/42 • Adverse event data was collected from baseline to 3 months following last administration of study treatment for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place