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NCT Number: NCT03969875

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interscalene catheter

Device

rescue catheters attached to a PCA pump

Liposomal bupivacaine

Drug

10 cc

Other names: Exparel

Dexamethasone

Drug

1 cc of 4mg

Bupivacaine

Drug

0.5% bupivacaine

Primary outcomes

  1. Numerical Rating Score for Pain

    Time frame: 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 outcomes

  1. Time to First Analgesic Request

    Time frame: Day 1

    Time to first analgesic request on Day 1

  2. Total Narcotic Consumption

    Time frame: hospital stay, up to 48 hours

    Total narcotic consumption in mg morphine equivalents (MME) during hospital stay

  3. Arm Weakness

    Time frame: 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

  4. Arm Numbness

    Time frame: 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.

  5. Time of Analgesia Duration

    Time frame: Day 1

    The duration for which the patient has no pain on Day 1

  6. Time of Motor Recovery

    Time frame: Day 1

    Time of motor recovery on Day 1

  7. Sensory Intact

    Time frame: 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.

  8. Hand Strength

    Time frame: 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.

  9. PACU Length of Stay

    Time frame: Day 1

    Post-anesthesia Care Unit length of stay in hours on Day 1

  10. Hospital Length of Stay

    Time frame: up to 3 days

    Length of stay for duration of hospital admission

  11. Number of Complication Events

    Time frame: up to 3 days

    Number of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea

  12. Number of Participants With Quality of Sleep Rating

    Time frame: average of 3 days

    Patient to rate their quality of sleep as good, average, or bad

  13. Number of Participants With Patient's Satisfaction

    Time frame: during the hospital stay, up to 3 days

    Number of Participants with Patient satisfaction. Patients were asked if they were satisfied.

  14. Change in Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 31, 2019
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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