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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Time; Brachial Plexus Block; Shoulder Surgery; Dexamethasone; Intravenous Drug Usage
• Intervention / Treatment: Drug: dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preoperative group; Intravenous dexamethasone (5mg) is used when ultrasound guided ISB is performed.	Drug: dexamethasone; Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine; Other Names: Dexamethasone Dexamethasone sodium phosphate
Active Comparator: postoperative group; Ultasound guided ISB is performed before operation and intravenous dexamethasone (5mg) is used in postoperative care unit ( PACU)	Drug: dexamethasone; Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine; Other Names: Dexamethasone Dexamethasone sodium phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of sensory block	from completion of ISB to VAS for pain > 0 ( in hours)	one day postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Opioid Consumption	Time from completion of block procedure to first consumption of opioid analgesic (in hours)	one day postoperative
Opioid Consumption	Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours	two days postoperative
Visual Analog Scale for pain ( from 0 to 10 )	Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.	7 days postoperative
Postoperative Serum Blood Glucose	Measured on the morning of first day after surgery	one day postoperative
Infection	Number of participants with localized infection at nerve block site	7 days postoperative
Number of Participants With Postoperative Nausea and/or Vomiting	Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively	7 days postoperative
Number of Participants With Nerve Damage From Interscalene Block	Persistent paresthesia, and sensory/motor block at 7 days	7 days postoperative

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Principal Investigator: Quanhong Zhou, MD., Ph.D, Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: 2020-186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No