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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714112
• Other study ID #: 2020-186
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2023
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Brachial Plexus Block
• Dexamethasone
• Intravenous Drug Usage
• Shoulder Surgery
• Time

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Jiaotong University affiliated Shanghai Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of sensory block	from completion of ISB to VAS for pain > 0 ( in hours)	one day postoperative
Secondary	Time to First Opioid Consumption	Time from completion of block procedure to first consumption of opioid analgesic (in hours)	one day postoperative
Secondary	Opioid Consumption	Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours and 48 hours	two days postoperative
Secondary	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
Secondary	Postoperative Serum Blood Glucose	Measured on the morning of first day after surgery	one day postoperative
Secondary	Infection	Number of participants with localized infection at nerve block site	7 days postoperative
Secondary	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
Secondary	Number of Participants With Nerve Damage From Interscalene Block	Persistent paresthesia, and sensory/motor block at 7 days	7 days postoperative