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Completed

NCT Number: NCT04714112

Low-dose Intravenous Dexamethasone at Different Times as Adjunvants for Brachial Plexus Blocks

Dexamethasone has been tested as an effective adjuvant to prolong the effect of local anesthetics for peripheral nerve blocks, both perineurally and intravenously. The purpose of this study is to investigate the effect of the addition of dexamethasone (5mg) at different time to a standard ropivacaine solution (0.5%) on analgesic duration of interscalene block.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

Shanghai, China

About this study

Interscalene brachial plexus block (ISB) is regarded as the standard of care for anesthesia and analgesia for shoulder surgery by providing the superior analgesia and reducing opioid consumption. After several hours when the effects of single injection ISB wear off, the patients often suffer moderate to severe pain of the surgical insult and required strong opioid analgesia. Efforts to prolong ISB duration by adding adjuvants to local anesthetic (eg. clonidine, dexmedetomidine) have been studied with promising results. Dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. Intravenous administration of dexamethasone was reported to have similar effects as perineural route indicating the possible mechanism for prolonging analgesic duration might be due to the systemic effects of dexamethasone. We hypothesized: should that is the reason, systemic administration of dexamethasone at different time may provide similar effects on the duration of peripheral nerve block. Dexamethasone is a slow effect cortisone with long half-time, it is widely used at the beginning of surgery to prevent postoperative nausea and vomiting. A trial that demonstrates enhanced block quality and duration associated with intravenous dexamethasone at different time may allow us to achieve prolonged duration of effect if dexamethasone is used in perioperative period for different purpose. This would further identify the possible mechanism of dexamethasone to prolong the analgesia effect of local anesthetics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing arthroscopic shoulder surgery at Shanghai Sixth People's Hospital.
  • ASA functional status class I to II
  • Age 18 to 70 years
  • BMI ≤ 35 kg/m2

Exclusion criteria

  • Lack of patient consent
  • Allergy to dexamethasone or ropivacaine
  • BMI > 35 kg/m2
  • Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  • Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  • Pregnant or nursing females
  • Chronic opioid use defined as > 30mg oral morphine or equivalent per day

Treatment and study plan

Dexamethasone

Drug

Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine

Other names: Dexamethasone Dexamethasone sodium phosphate

Primary outcomes

  1. Duration of sensory block

    Time frame: one day postoperative

    from completion of ISB to VAS for pain > 0 ( in hours)

Secondary outcomes

  1. Time to First Opioid Consumption

    Time frame: one day postoperative

    Time from completion of block procedure to first consumption of opioid analgesic (in hours)

  2. Opioid Consumption

    Time frame: two days postoperative

    Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours

  3. Visual Analog Scale for pain ( from 0 to 10 )

    Time frame: 7 days postoperative

    Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.

  4. Postoperative Serum Blood Glucose

    Time frame: one day postoperative

    Measured on the morning of first day after surgery

  5. Infection

    Time frame: 7 days postoperative

    Number of participants with localized infection at nerve block site

  6. Number of Participants With Postoperative Nausea and/or Vomiting

    Time frame: 7 days postoperative

    Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively

  7. Number of Participants With Nerve Damage From Interscalene Block

    Time frame: 7 days postoperative

    Persistent paresthesia, and sensory/motor block at 7 days

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
Jan 26, 2023

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

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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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