Total Shoulder ArthroplastyNCT03969875
Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
A study testing Interscalene catheter, Liposomal bupivacaine and Dexamethasone in people with Total Shoulder Arthroplasty and Shoulder Osteoarthritis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Shoulder Arthroplasty, Shoulder Osteoarthritis
- What is being tested?
- Interscalene catheter, Liposomal bupivacaine and Dexamethasone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2018to 5 Apr 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients between age 18-80 years undergoing elective primary total shoulder arthroplasty procedure.
- All patients who speak read and understand English will be included for follow up purposes.
Who cannot join
- Patient refusal
- ASA 5
- presence of coagulopathy
- severe lung disease
- contralateral diaphragmatic palsy
- insulin-dependent diabetes
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- hepatic disease/failure
- kidney disease/failure
- pregnancy
- chronic opioid use (defined as opioid use for >3 months), or allergy to any of the study medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison of the Analgesic Efficacy of a Single Shot Interscalene Block With Liposomal Bupivacaine to Bupivacaine With Dexamethasone as an adjuvant-a Randomized Controlled Trial
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene block either as single shot or as a catheter is an established modality for effective analgesia which facilitates early mobilization helping in physical therapy and early discharge.
With the help of local anesthetic injected as a single shot, analgesia usually lasts less than 24 hours. Recent research in regional anesthesia is advancing towards adjuvants which will prolong the duration of local anesthesia. This has introduced the concept of "multimodal perineural analgesia (MMPNA)" whereby multiple agents with differing mechanisms of action are used with the goal of providing perineural analgesia while avoiding exposure to high and potentially toxic levels of individual agents. Some of the commonly used adjuvants in clinical studies are fentanyl, buprenorphine, morphine, tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, dexmedetomidine, dexamethasone, neostigmine and potassium. They find a distinct place in wide spread clinical practice as an off-label use.
Read more
Steroids have a long history of safe use in epidural space for treatment of radicular pain due to nerve irritation. Dexamethasone is used routinely as a part of anti- emetic prophylaxis and anti-inflammatory effect. Methyl prednisone was the first steroid to be used as an adjuvant. Dexamethasone was first used as an adjuvant in 2003.
It has been hypothesized that steroids induce a degree of vasoconstriction, thereby reducing local anesthetic absorption, tend to have an opioid sparing effect. Another theory suggests that it increases the activity of inhibitory potassium channels on nociceptive C-fibers (via glucocorticoid receptors), thus decreasing their activity.
Several studies have demonstrated promising results with the use of 8mg of perineural dexamethasone. No neuronal injury has been reported in in vivo studies. Though there are several studies which report usage of dexamethasone in varying doses of 2mg to 8mg, the optimal effective dose of dexamethasone as an adjuvant for nerve block remains unknown. Some studies have suggested perineural is more effective than IV as an adjuvant .
Liposomal bupivacaine, a formulation where bupivacaine is encapsulated into multivesicular liposomes, making it a slow and controlled release from the liposomes, was originally indicated for wound infiltration at the surgical site to provide post-surgical analgesia. Studies have demonstrated efficacy up to 24 hours in femoral nerve block in total knee arthroplasty. Recent approval of liposomal bupivacaine in interscalene block for shoulder surgeries by FDA opens an arena unexplored in the world of regional anesthesia.
Current opioid epidemic, a crisis in health care forces healthcare providers to consider alternate analgesic modalities without compromising patient comfort. Regional anesthesia has revolutionized peri-operative pain management by avoiding opioids and their side effects. Use of adjuvants to the current regional techniques holds promise in postsurgical analgesia.
The researchers propose to compare the analgesic efficacy of liposomal bupivacaine to bupivacaine with dexamethasone as an adjuvant in interscalene block with catheters for shoulder surgeries. Till date, there is not a single study comparing the three in current literature.
Read the detailed description
There have been several studies demonstrating efficacy of dexamethasone in prolonging the analgesic effect when administered both perineurally and intra-venously as an adjuvant to local anesthesia demonstrating a dose effect relationship. Liposomal bupivacaine has shown promising results in total knee arthroplasty and there are a limited number of studies demonstrating efficacy in total shoulder arthroplasty.
If by comparing dexamethasone as an adjuvant to bupivacaine and liposomal formulation is deciphered, it can help in avoiding costs associated with liposomal bupivacaine extending post-operative analgesia avoiding narcotics and reducing health care costs. And comparing the two to the standard catheters helps us understand if they have a role in pain management in the future.
- Being tested
- Interscalene catheter, Liposomal bupivacaine, Dexamethasone, Bupivacaine
- Keywords
- Liposomal bupivacaine, Dexamethasone, Interscalene catheter, Interscalene single shot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene catheterDevice
rescue catheters attached to a PCA pump
Liposomal bupivacaineDrug
Also called Exparel
10 cc
DexamethasoneDrug
1 cc of 4mg
BupivacaineDrug
0.5% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Interscalene catheter | Active comparator | Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour. Receives: Device: Interscalene catheter; Drug: Bupivacaine |
| Interscalene single shot with liposomal bupivacaine | Experimental | Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion. Receives: Drug: Liposomal bupivacaine |
| Interscalene with bupivacaine and dexamethasone | Experimental | Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion. Receives: Drug: Dexamethasone; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Score for Pain
Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.
Measured: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours
Secondary outcomes (14)
Time to First Analgesic Request
Time to first analgesic request on Day 1
Measured: Day 1
Total Narcotic Consumption
Total narcotic consumption in mg morphine equivalents (MME) during hospital stay
Measured: hospital stay, up to 48 hours
Arm Weakness
Arm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness
Measured: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
Arm Numbness
Arm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation.
Measured: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
Time of Analgesia Duration
The duration for which the patient has no pain on Day 1
Measured: Day 1
Time of Motor Recovery
Time of motor recovery on Day 1
Measured: Day 1
Sensory Intact
Sensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation.
Measured: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
Hand Strength
Hand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms.
Measured: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours
PACU Length of Stay
Post-anesthesia Care Unit length of stay in hours on Day 1
Measured: Day 1
Hospital Length of Stay
Length of stay for duration of hospital admission
Measured: up to 3 days
Number of Complication Events
Number of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea
Measured: up to 3 days
Number of Participants With Quality of Sleep Rating
Patient to rate their quality of sleep as good, average, or bad
Measured: average of 3 days
Number of Participants With Patient's Satisfaction
Number of Participants with Patient satisfaction. Patients were asked if they were satisfied.
Measured: during the hospital stay, up to 3 days
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
PROMIS global assessment assesses physical and mental activities of daily living scored from 0 (poor) to 5 (excellent) at first post-operative visit as compared to baseline. Each scale from 0-100, higher score indicates better health outcomes.
Measured: baseline and one week post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start18 Aug 2018
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meg Rosenblatt, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969875
- Sponsor's protocol ID
- GCO 18-1264
- Status last verified
- Apr 2024
- First submitted
- 29 May 2019
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
PubMed 28157791Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
PubMed 23587874Bishop JY, Sprague M, Gelber J, Krol M, Rosenblatt MA, Gladstone J, Flatow EL. Interscalene regional anesthesia for shoulder surgery. J Bone Joint Surg Am. 2005 May;87(5):974-9. doi: 10.2106/JBJS.D.02003.
PubMed 15866958