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

NCT03969875 | Completed Results DMC

• 1 other identifier: GCO 18-1264
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Shoulder Arthroplasty; Shoulder Osteoarthritis

Keywords

Liposomal bupivacaine; Dexamethasone; Interscalene catheter; Interscalene single shot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Time to First Analgesic Request

  Day 1

• Total Narcotic Consumption

  hospital stay, up to 48 hours

• Arm Weakness

  at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

• Arm Numbness

  at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

• Time of Analgesia Duration

  Day 1

Study Arms (3)

Interscalene catheter

ACTIVE COMPARATOR

Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.

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.

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.

Drug: Dexamethasone; Drug: Bupivacaine

Interventions

Interscalene catheter DEVICE

rescue catheters attached to a PCA pump

Interscalene catheter

Liposomal bupivacaine DRUG

10 cc

Also known as: Exparel

Interscalene single shot with liposomal bupivacaine

Dexamethasone DRUG

1 cc of 4mg

Interscalene with bupivacaine and dexamethasone

Bupivacaine DRUG

0.5% bupivacaine

Interscalene catheter; Interscalene with bupivacaine and dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

• 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.

  PMID: 28157791 BACKGROUND

• 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.

  PMID: 23587874 BACKGROUND

• 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.

  PMID: 15866958 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; Bupivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Poonam Pai
• Organization: Icahn School of Medicine at Mount Sinai

poonam.paibantwalhebbalasankatte@mountsinai.org

212-523-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: August 18, 2018
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)