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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Completed
Phase 4

Conditions

Time
Brachial Plexus Block
Shoulder Surgery
Analgesia
Intravenous Drug Usage
Dexamethasone

Treatments

Drug: dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT04714112
2020-186

Details and patient eligibility

About

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.

Full description

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.

Enrollment

180 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

  1. Lack of patient consent
  2. Allergy to dexamethasone or ropivacaine
  3. BMI > 35 kg/m2
  4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  5. 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
  6. Pregnant or nursing females
  7. Chronic opioid use defined as > 30mg oral morphine or equivalent per day

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

180 participants in 2 patient groups

preoperative group
Experimental group
Description:
Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed.
Treatment:
Drug: dexamethasone
postoperative group
Active Comparator group
Description:
Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU)
Treatment:
Drug: dexamethasone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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