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Dexamethasone at Lower Concentration Ropivacaine in the Supraclavicular Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572686
Recruitment Status : Unknown
Verified April 2018 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Analgesia Motor Activity Brachial Plexus Block Drug: Ropivacaine 0.5% 20mL Drug: Ropivacaine 0.25% 20ml Drug: Ropivacaine 0.25% 20ml + dexamethasone 8mg Not Applicable

Detailed Description:

The supraclavicular brachial plexus block is widely used in upper limb surgery below the shoulder. Although it is easier and more stable than axillary nerve block and subclavian brachial plexus block, long-acting local anesthetics are used for long-term blockade with traditional block methods. 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.

Ropivacaine is a novel long-acting topical amine amine topical anesthetics that lasts long and has anesthetic and analgesic effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor block separation at low concentrations more obvious, and with the external peripheral vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia. Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for tuberculosis patients. It is becoming more common to use steroids as an adjunct to local anesthetics in brachial plexus block. Steroids have neurological blockade effects by blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has also been widely studied recently.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of the Effects of Adding Dexamethasone at 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Supraclavicular Brachial Plexus Block
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Sham Comparator: Group Ropivacaine High (RH)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.5% 20ml + N/S 1.6mL.
Drug: Ropivacaine 0.5% 20mL
In Group RH, participants received supraclavicular brachial plexus block with ropivacaine 0.5% 20ml at the end of surgery.
Other Name: Ropivacaine high concentration 20ml

Placebo Comparator: Group Ropivacaine Low (RL)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.25% 20ml + N/S 1.6mL.
Drug: Ropivacaine 0.25% 20ml
In Group RL, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml at the end of surgery.
Other Name: Ropivacaine low concentration 20ml

Experimental: Group Ropivacaine Low + Dexamethasone (RLD)
Ultrasound-guided supraclavicular brachial plexus block with Ropivacaine 0.25% 20ml + Dexamethasone 8mg (1.6mL).
Drug: Ropivacaine 0.25% 20ml + dexamethasone 8mg
In Group RLD, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml + dexamethasone 8mg at the end of surgery.
Other Name: Ropivacaine low concentration 20ml + dexamethasone 8mg




Primary Outcome Measures :
  1. analgesic effects (the intensity of pain) [ Time Frame: 24 hours after the end of surgery ]
    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.


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 1 hour after the end of surgery ]
    systolic, diastolic, and mean blood pressure in the recovery room

  2. motor block [ Time Frame: 24 hours after the end of surgery ]
    Motor nerve block is evaluated using Lovett Rating Scale. 0 = complete blockage, 1 = almost complete blockage, 2 = significant motion impairment, 3 = mild motion impairment, 4 = significant loss of strength, 5 = slight decrease in strength, 6 = normal strength.

  3. heart rate [ Time Frame: 1 hour after the end of surgery ]
    heart rate in the recovery room


Other Outcome Measures:
  1. postoperative nausea [ Time Frame: 24 hours after the end of surgery ]
    Nausea was graded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

  2. postoperative vomiting [ Time Frame: 24 hours after the end of surgery ]
    vomiting was graded as 0 = no, 1 = 1, 2 = 2, and 3 = 3 or more episodes



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572686


Locations
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Taiwan
Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City, Taiwan, 801
Kaohsiung Medical University Hosptial
Kaohsiung City, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Director: Hung-Te Hsu, MD/PhD Department of anesthesiology,Kaohsiung Municipal Ta-Tung Hospital , Kaohsiung City 801,Taiwan (R.O.C.)
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03572686    
Other Study ID Numbers: KMUHIRB-F(I)-20180034
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
supraclavicular nerve block
dexamethasone
Ropivacaine
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents