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

Phase 4

Completed

• Conditions: Shoulder Surgery; Analgesia; Dexamethasone; Intravenous Drug Usage; Brachial Plexus Block; Time
• Interventions: Drug: dexamethasone

• Registration Number: NCT04714112
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-10
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-19
• Primary Completion: 2021-05-31
• Study Completion: 2021-07-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preoperative group	dexamethasone	Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed.
postoperative group	dexamethasone	Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU)

Primary Outcome Measures

Name	Time	Method
Duration of sensory block	one day postoperative	from completion of ISB to VAS for pain \> 0 ( in hours)

Secondary Outcome Measures

Name	Time	Method
Time to First Opioid Consumption	one day postoperative	Time from completion of block procedure to first consumption of opioid analgesic (in hours)
Opioid Consumption	two days postoperative	Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours
Visual Analog Scale for pain ( from 0 to 10 )	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.
Postoperative Serum Blood Glucose	one day postoperative	Measured on the morning of first day after surgery
Infection	7 days postoperative	Number of participants with localized infection at nerve block site
Number of Participants With Postoperative Nausea and/or Vomiting	7 days postoperative	Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Number of Participants With Nerve Damage From Interscalene Block	7 days postoperative	Persistent paresthesia, and sensory/motor block at 7 days

Trial Locations

Locations (1)

Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China