Joint Disease, Pain, Pain, Acute, Pain, Chronic
Conditions
Brief summary
Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).
Interventions
DRUGBupivacaine
Anesthetic that will help treat pain and sensation after shoulder arthroscopy
DEVICEUltrasound
Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder * Age 18 to 80 years * Planned use of general anesthesia with LMA and interscalene or superior trunk block * Ability to follow study protocol * English speaking * ASA I - III
Exclusion criteria
Pre-existing neuropathy of the operative limb * Younger than 18 years old and older than 80 * Patients with pulmonary severe respiratory disease * Allergy to one of the study medications * Chronic gabapentin/pregabalin use (regular use for longer than 3 months) * Chronic opioid use (taking opioids for longer than 3 months) * Contraindication to general anesthesia, interscalene or superior trunk block * Herniated Cervical Disk, Cervical Myelopathy * BMI \>35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers | Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery. |
| Numerical Pain Rating System (NRS) Pain Scores | Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System | Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System. Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Duration | Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call. | Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interscalene Block (ISB) The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks | 63 |
| Superior Trunk Block (STB) The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | Interscalene Block (ISB) | Total | Superior Trunk Block (STB) |
|---|---|---|---|
| Age, Continuous | 50.0 years | 51 years | 51.5 years |
| ASA Class ASA 1 | 18 participants | 28 participants | 10 participants |
| ASA Class ASA 2 | 44 participants | 96 participants | 52 participants |
| ASA Class ASA 3 | 1 participants | 2 participants | 1 participants |
| Baseline NRS | 2.0 units on a scale | 2.0 units on a scale | 2.0 units on a scale |
| BMI | 26.8 kg/m^2 | 26.8 kg/m^2 | 27.2 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 116 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Laterality LEFT Shoulder Arthroscopy | 28 participants | 51 participants | 23 participants |
| Laterality Right Shoulder Arthroscopy | 35 participants | 75 participants | 40 participants |
| Length of Surgery | 46.0 minutes | 48 minutes | 49.0 minutes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 52 Participants | 106 Participants | 54 Participants |
| Sex: Female, Male Female | 19 Participants | 33 Participants | 14 Participants |
| Sex: Female, Male Male | 44 Participants | 93 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.
Time frame: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interscalene Block (ISB) | Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | HDP | 45 participants |
| Interscalene Block (ISB) | Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | No HDP | 18 participants |
| Superior Trunk Block (STB) | Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | HDP | 3 participants |
| Superior Trunk Block (STB) | Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP) | No HDP | 59 participants |
Primary
Numerical Pain Rating System (NRS) Pain Scores
Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System. Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.
Time frame: Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Block (ISB) | Numerical Pain Rating System (NRS) Pain Scores | 0 units on a scale |
| Superior Trunk Block (STB) | Numerical Pain Rating System (NRS) Pain Scores | 0 units on a scale |
Secondary
Block Duration
Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
Time frame: Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interscalene Block (ISB) | Block Duration | 23.18 Hours |
| Superior Trunk Block (STB) | Block Duration | 23.15 Hours |