Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone

Completed

Conditions: Total Shoulder Arthroplasty
Shoulder Osteoarthritis

Interventions: Drug: Liposomal bupivacaine
Drug: Dexamethasone
Device: Interscalene catheter
Drug: Bupivacaine

Registration Number: NCT03969875

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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. 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.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

Patient refusal
ASA 5
presence of coagulopathy
severe lung disease
contralateral diaphragmatic palsy
insulin-dependent diabetes
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interscalene single shot with liposomal bupivacaine	Liposomal bupivacaine	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.
Interscalene with bupivacaine and dexamethasone	Dexamethasone	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.
Interscalene catheter	Interscalene catheter	Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.
Interscalene with bupivacaine and dexamethasone	Bupivacaine	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.
Interscalene catheter	Bupivacaine	Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Score for Pain	at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours	Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.

Secondary Outcome Measures

Name	Time	Method
Arm Weakness	at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours	Arm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness
Time of Motor Recovery	Day 1	Time of motor recovery on Day 1
Sensory Intact	at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours	Sensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation.
Hand Strength	at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours	Hand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms.
Total Narcotic Consumption	hospital stay, up to 48 hours	Total narcotic consumption in mg morphine equivalents (MME) during hospital stay
PACU Length of Stay	Day 1	Post-anesthesia Care Unit length of stay in hours on Day 1
Hospital Length of Stay	up to 3 days	Length of stay for duration of hospital admission
Number of Complication Events	up to 3 days	Number of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea
Change in Patient Reported Outcomes Measurement Information System (PROMIS)	baseline and one week post-op	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.
Time to First Analgesic Request	Day 1	Time to first analgesic request on Day 1
Arm Numbness	at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours	Arm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation.
Time of Analgesia Duration	Day 1	The duration for which the patient has no pain on Day 1
Number of Participants With Quality of Sleep Rating	average of 3 days	Patient to rate their quality of sleep as good, average, or bad
Number of Participants With Patient's Satisfaction	during the hospital stay, up to 3 days	Number of Participants with Patient satisfaction. Patients were asked if they were satisfied.