Fracture of Shoulder and Upper Arm
Conditions
Brief summary
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
Detailed description
liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.
Interventions
DRUG1.3% Liposomal Bupivacaine
local tissue infiltration of Liposomal Bupivacaine during surgery
DRUG0.125% Bupivacaine
Continues nerve block with Bupivacaine during surgery and postoperatively
Sponsors
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing shoulder arthroplasty under general anesthesia * Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia * Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3 * Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines. * Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond. * Patients available for follow up routine post-operative clinic visits, per standard of care.
Exclusion criteria
* Contraindications to regional anesthesia * Significant peripheral neuropathy or neurological disorder affecting the upper extremity * Contraindication to a component of multimodal analgesia * Pregnancy * Opioid tolerance * Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Analgesia | 30 days | Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative American Shoulder and Elbow Surgeons (ASES) | Preoperative, 6 weeks and last follow up | American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome. |
| Subjective Shoulder Value (SSV) | Pre-operative, 6 weeks and last Follow up | Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100% |
| Incidence of Nerve Injury | During hospital stay and at 2 weeks and 6 weeks post-operatively | Neuropraxia on the treatment side |
| Post Operative Opioid Consumption | During hospital stay up to 48 hours after surgery | Cumulative amount of opioids administered during the time frame |
Countries
United States
Participant flow
Recruitment details
This prospective, randomized, controlled study included 70 consecutive shoulder arthroplasty patients from August 2015 through June 2016 during the period of 1 year at one location.
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine A One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery | 34 |
| CISB Control for A Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively | 36 |
| Total | 70 |
Baseline characteristics
| Characteristic | CISB Control for A | Total | Liposomal Bupivacaine A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 70 Participants | 34 Participants |
| Arthroplasty type Hemi | 1 participants | 2 participants | 1 participants |
| Arthroplasty type Reverse | 20 participants | 36 participants | 16 participants |
| Arthroplasty type Total | 15 participants | 32 participants | 17 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 36 participants | 70 participants | 34 participants |
| Sex: Female, Male Female | 17 Participants | 26 Participants | 9 Participants |
| Sex: Female, Male Male | 19 Participants | 44 Participants | 25 Participants |
| Surgical Side Left | 17 Participants | 35 Participants | 18 Participants |
| Surgical Side Right | 19 Participants | 35 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 36 |
| other Total, other adverse events | 1 / 34 | 7 / 36 |
| serious Total, serious adverse events | 1 / 34 | 0 / 36 |
Outcome results
Primary
Quality of Analgesia
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Time frame: 30 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Liposomal Bupivacaine A | Quality of Analgesia | At 24 to 48 hours | 2.1 score on a scale |
| Liposomal Bupivacaine A | Quality of Analgesia | Day 7 | 3.4 score on a scale |
| Liposomal Bupivacaine A | Quality of Analgesia | Day 2 | 4.1 score on a scale |
| Liposomal Bupivacaine A | Quality of Analgesia | Day 30 | 2.0 score on a scale |
| CISB Control for A | Quality of Analgesia | Day 2 | 4.0 score on a scale |
| CISB Control for A | Quality of Analgesia | At 24 to 48 hours | 2.6 score on a scale |
| CISB Control for A | Quality of Analgesia | Day 30 | 2.2 score on a scale |
| CISB Control for A | Quality of Analgesia | Day 7 | 2.6 score on a scale |
Secondary
Incidence of Nerve Injury
Neuropraxia on the treatment side
Time frame: During hospital stay and at 2 weeks and 6 weeks post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine A | Incidence of Nerve Injury | 0 Participants |
| CISB Control for A | Incidence of Nerve Injury | 0 Participants |
Secondary
Post Operative American Shoulder and Elbow Surgeons (ASES)
American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.
Time frame: Preoperative, 6 weeks and last follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine A | Post Operative American Shoulder and Elbow Surgeons (ASES) | Pre-operative | 36.1 score on a scale | Standard Deviation 20.04 |
| Liposomal Bupivacaine A | Post Operative American Shoulder and Elbow Surgeons (ASES) | 6 Weeks after surgery | 59.5 score on a scale | Standard Deviation 18.1 |
| Liposomal Bupivacaine A | Post Operative American Shoulder and Elbow Surgeons (ASES) | Last Followup | 74.5 score on a scale | Standard Deviation 22.7 |
| CISB Control for A | Post Operative American Shoulder and Elbow Surgeons (ASES) | 6 Weeks after surgery | 57.3 score on a scale | Standard Deviation 16.2 |
| CISB Control for A | Post Operative American Shoulder and Elbow Surgeons (ASES) | Pre-operative | 27.7 score on a scale | Standard Deviation 15.7 |
| CISB Control for A | Post Operative American Shoulder and Elbow Surgeons (ASES) | Last Followup | 59.7 score on a scale | Standard Deviation 20.5 |
Secondary
Post Operative Opioid Consumption
Cumulative amount of opioids administered during the time frame
Time frame: During hospital stay up to 48 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine A | Post Operative Opioid Consumption | 78.6 Total MME per Group |
| CISB Control for A | Post Operative Opioid Consumption | 52.8 Total MME per Group |
Secondary
Subjective Shoulder Value (SSV)
Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%
Time frame: Pre-operative, 6 weeks and last Follow up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Liposomal Bupivacaine A | Subjective Shoulder Value (SSV) | Preoperative | 30.7 score on a scale |
| Liposomal Bupivacaine A | Subjective Shoulder Value (SSV) | at 6 weeks post-op | 55.7 score on a scale |
| Liposomal Bupivacaine A | Subjective Shoulder Value (SSV) | At last follow up | 70.0 score on a scale |
| CISB Control for A | Subjective Shoulder Value (SSV) | Preoperative | 24.3 score on a scale |
| CISB Control for A | Subjective Shoulder Value (SSV) | at 6 weeks post-op | 63.1 score on a scale |
| CISB Control for A | Subjective Shoulder Value (SSV) | At last follow up | 69.3 score on a scale |