Shoulder Arthroscopy
Conditions
Keywords
Shoulder, Rotator Cuff, Epinephrine, Subacromial bursa
Brief summary
The purpose of this study is to evaluate surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery.
Interventions
Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space
Exclusion criteria
* Are unable to provide informed consent * Non-English speaker * Have a history of adverse medication reaction to epinephrine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale | end of surgery(about 30-120 minutes from start of surgery) | This scale is scored from 1-10, a higher number indicating better clarity |
| Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure | From start of surgery to end of surgery(about 30-120 minutes) | The pump pressure is initially set at 35mmHg during the arthroscopic surgical procedure. If visualization is limited during the procedure, surgeons may increase the pump pressure of arthroscopic fluid within the shoulder during the procedure. This outcome measure reports the percentage of participants for whom intra-operative arthroscopic pump pressure was increased to 45mmHg or higher during the surgical procedure. |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Mean Arterial Pressure | end of surgery(about 30-120 minutes from start of surgery) |
| Total Operative Time | end of surgery(about 30-120 minutes from start of surgery) |
| Number of Subjects Who Experience Intraoperative Adverse Events | end of surgery(about 30-120 minutes from start of surgery) |
| Number of Subjects Who Experience Post Operative Adverse Events | from the end of surgery up to 2 weeks post surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Bupivacaine with Epinephrine: Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Study patients will receive an injection containing a total volume of 20 mL of bupivacaine with epinephrine (0.3 mL epinephrine in 30 mL of 0.5% bupivacaine).The syringe will not be labeled, and the contents of the injection will not be disclosed to the surgeon to preserve blinding. The injection will be performed with an 18-gauge needle into the subacromial space via a posterior or lateral approach after positioning the patient in the beach chair position, but prior to prepping and draping.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale. Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded. | 30 |
| Control Group Bupivacaine alone: Randomization will be performed prior to surgery and group designation will be placed within an opaque envelope in the patient's chart.The circulating nurse will prepare the pre-operative injection. Control patients will receive an injection containing 20mL of 0.5% bupivacaine alone.Throughout the case, the mean arterial pressure of the patient will be monitored. At the conclusion of the surgical procedure, the surgeon will rate visual clarity on a visual analog scale.Changes in pump pressure from the initial pressure of 35mmHg during the surgical procedure will also be recorded. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Control Group | Total | Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 11 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 49 Participants | 23 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 16 Participants | 28 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure
The pump pressure is initially set at 35mmHg during the arthroscopic surgical procedure. If visualization is limited during the procedure, surgeons may increase the pump pressure of arthroscopic fluid within the shoulder during the procedure. This outcome measure reports the percentage of participants for whom intra-operative arthroscopic pump pressure was increased to 45mmHg or higher during the surgical procedure.
Time frame: From start of surgery to end of surgery(about 30-120 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure | 22 percent |
| Control Group | Percentage of Participants for Whom Intra-operative Arthroscopic Pump Pressure Was Increased to 45mmHg or Higher During the Surgical Procedure | 23 percent |
Primary
Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale
This scale is scored from 1-10, a higher number indicating better clarity
Time frame: end of surgery(about 30-120 minutes from start of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale | 8.3 score on a scale | Standard Deviation 1.4 |
| Control Group | Surgeon-rated Visual Clarity as Assessed by the Visual Analog Scale | 7.5 score on a scale | Standard Deviation 1.8 |
Secondary
Intraoperative Mean Arterial Pressure
Time frame: end of surgery(about 30-120 minutes from start of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Intraoperative Mean Arterial Pressure | 70.5 mmHg | Standard Deviation 12.7 |
| Control Group | Intraoperative Mean Arterial Pressure | 71.3 mmHg | Standard Deviation 7.3 |
Secondary
Number of Subjects Who Experience Intraoperative Adverse Events
Time frame: end of surgery(about 30-120 minutes from start of surgery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Subjects Who Experience Intraoperative Adverse Events | 0 Participants |
| Control Group | Number of Subjects Who Experience Intraoperative Adverse Events | 0 Participants |
Secondary
Number of Subjects Who Experience Post Operative Adverse Events
Time frame: from the end of surgery up to 2 weeks post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Subjects Who Experience Post Operative Adverse Events | 0 Participants |
| Control Group | Number of Subjects Who Experience Post Operative Adverse Events | 0 Participants |
Secondary
Total Operative Time
Time frame: end of surgery(about 30-120 minutes from start of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Operative Time | 62 minutes | Standard Deviation 19.4 |
| Control Group | Total Operative Time | 64 minutes | Standard Deviation 30.1 |