A Phase 4 interventional study of Bupivacaine and Ultrasound in Joint Disease, Pain and Pain, Acute, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment
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).
386 studies on the registry are indexed under Joint Diseases; 64 are open to participants now.
This study's enrollment of 126 is above the median of 102 across 251 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pre-existing neuropathy of the operative limb
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bupivacaine · Device: Ultrasound
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.
Drug: Bupivacaine · Device: Ultrasound
Anesthetic that will help treat pain and sensation after shoulder arthroscopy
Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
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
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
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.
| Milestone | Interscalene Block (ISB) | Superior Trunk Block (STB) |
|---|---|---|
| Started | 63 | 63 |
| Completed | 63 | 63 |
| Not completed | 0 | 0 |
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.
| participants | Interscalene Block (ISB) | Superior Trunk Block (STB) |
|---|---|---|
| HDP | 45 | 3 |
| No HDP | 18 | 59 |
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.
| units on a scale | Interscalene Block (ISB) | Superior Trunk Block (STB) |
|---|---|---|
| Numerical Pain Rating System (NRS) Pain Scores | 0 (0 to 2) | 0 (0 to 3) |
Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
| Hours | Interscalene Block (ISB) | Superior Trunk Block (STB) |
|---|---|---|
| Block Duration | 23.18 (19.95 to 25.53) | 23.15 (19.12 to 30.07) |
Collected over From Post Op Day 1 to Post Op Day 7. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interscalene Block (ISB) | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| Superior Trunk Block (STB) | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| Age, Continuous(years) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| Median | 50.0 (38.0 to 59.0) | 51.5 (37.0 to 60.0) | 51 (37 to 59) |
| Sex: Female, Male(Participants) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| Female | 19 | 14 | 33 |
| Male | 44 | 49 | 93 |
| Ethnicity (NIH/OMB)(Participants) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 8 |
| Not Hispanic or Latino | 58 | 58 | 116 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 4 | 4 | 8 |
| White | 52 | 54 | 106 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 4 | 9 |
| BMI(kg/m^2) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| Median | 26.8 (24.4 to 29.6) | 27.2 (24.8 to 29.8) | 26.8 (24.8 to 29.8) |
| Length of Surgery(minutes) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| Median | 46.0 (35.0 to 66.0) | 49.0 (32.0 to 62.0) | 48 (33 to 63) |
| ASA Class(participants) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| ASA 1 | 18 | 10 | 28 |
| ASA 2 | 44 | 52 | 96 |
| ASA 3 | 1 | 1 | 2 |
| Laterality(participants) | Interscalene Block (ISB) | Superior Trunk Block (STB) | Total |
|---|---|---|---|
| LEFT Shoulder Arthroscopy | 28 | 23 | 51 |
| Right Shoulder Arthroscopy | 35 | 40 | 75 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Bupivacaine
Hospital for Special Surgery, New York →