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

Shoulder Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969875
• Other study ID #: GCO 18-1264
• Status: Completed
• Start date: August 18, 2018
• Est. completion date: April 5, 2022

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 5, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Osteoarthritis
• Total Shoulder Arthroplasty

Intervention

Device:
• Interscalene catheter
rescue catheters attached to a PCA pump

Drug:
• Liposomal bupivacaine
10 cc
• Dexamethasone
1 cc of 4mg
• Bupivacaine
0.5% bupivacaine

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (3)

Abdallah 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. — View Citation

Bishop 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. — View Citation

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. — View Citation

Outcome

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