Dexamethasone at Lower Concentration Ropivacaine in the Supraclavicular Nerve Block

NCT03572686 | Unknown DMC

• 1 other identifier: KMUHIRB-F(I)-20180034
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The supraclavicular brachial plexus block is widely used in upper limb surgery below the shoulder. However, this can easily lead to long-term motor nerve blockage, Horner's syndrome, phrenic nerve paralysis or systemic poisoning, and even serious side effects such as cardiac arrest. Dexamethasone is a synthetic corticosteroid and becoming more common to use steroids as an adjunct to local anesthetics in brachial plexus block. In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the supraclavicular arm, reducing the local anesthetic concentration is a feasible method, but this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia.Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative supraclavicular brachial plexus blockade with the addition of Dexamethasone 5mg to Ropivacaine (0.5%) alone and Ropivacaine (0.25%) in low concentrations.

Conditions

Analgesia; Motor Activity; Brachial Plexus Block

Keywords

supraclavicular nerve block; dexamethasone; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• analgesic effects (the intensity of pain)

  The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to quantify their degree of pain; where 0 means no pain and 10 conceivably the worst pain.

  24 hours after the end of surgery

Secondary Outcomes (3)

• blood pressure

  1 hour after the end of surgery

• motor block

  24 hours after the end of surgery

• heart rate

  1 hour after the end of surgery

Other Outcomes (2)

• postoperative nausea

  24 hours after the end of surgery

• postoperative vomiting

  24 hours after the end of surgery

Study Arms (3)

Group Ropivacaine High (RH)

SHAM COMPARATOR

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml + N/S 1.6mL.

Drug: Ropivacaine 0.5% 20mL

Group Ropivacaine Low (RL)

PLACEBO COMPARATOR

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.25% 20ml + N/S 1.6mL.

Drug: Ropivacaine 0.25% 20ml

Group Ropivacaine Low + Dexamethasone (RLD)

EXPERIMENTAL

Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.25% 20ml + Dexamethasone 8mg (1.6mL).

Drug: Ropivacaine 0.25% 20ml + dexamethasone 8mg

Interventions

Ropivacaine 0.5% 20mL DRUG

In Group RH, participants received supraclavicular brachial plexus block with ropivacaine 0.5% 20ml at the end of surgery.

Also known as: Ropivacaine high concentration 20ml

Group Ropivacaine High (RH)

Ropivacaine 0.25% 20ml DRUG

In Group RL, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml at the end of surgery.

Also known as: Ropivacaine low concentration 20ml

Group Ropivacaine Low (RL)

Ropivacaine 0.25% 20ml + dexamethasone 8mg DRUG

In Group RLD, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml + dexamethasone 8mg at the end of surgery.

Also known as: Ropivacaine low concentration 20ml + dexamethasone 8mg

Group Ropivacaine Low + Dexamethasone (RLD)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of Anesthesiology classification: I \~ III
• patients who have undergone arm surgery for blockage of the upper clavicle from nerve block

You may not qualify if:

• Patients had brachial plexus degeneration, coagulation abnormalities, obvious heart, lung, liver or kidney disease, body mass index less than 18.5 or greater than 35, body weight greater than 80 kg, pregnancy, regular use of steroids or opiates Opioids, chronic medication or alcohol abuse, as well as previous allergies or adverse reactions to opiates, dexamethasone, or the use of topical anesthetic Ropivacaine, were excluded from this study.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (2)

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, 801, Taiwan

Location

Kaohsiung Medical University Hosptial

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Agnosia; Motor Activity

Interventions

Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hung-Te Hsu, MD/PhD

  Department of anesthesiology,Kaohsiung Municipal Ta-Tung Hospital , Kaohsiung City 801，Taiwan (R.O.C.)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: June 28, 2018
• Study Start: April 13, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 28, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)