Dexamethasone at Lower Concentration Ropivacaine in the Supraclavicular Nerve Block

Comparison of the Effects of Adding Dexamethasone at 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Supraclavicular Brachial Plexus Block

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.

Study Overview

• Status: Unknown
• Conditions: Analgesia; Motor Activity; Brachial Plexus Block
• Intervention / Treatment: Drug: Ropivacaine 0.5% 20mL; Drug: Ropivacaine 0.25% 20ml; Drug: Ropivacaine 0.25% 20ml + dexamethasone 8mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 801
    • Kaohsiung Municipal Ta-Tung Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Ropivacaine low concentration 20ml + dexamethasone 8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	systolic, diastolic, and mean blood pressure in the recovery room	1 hour after the end of surgery
motor block	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.	24 hours after the end of surgery
heart rate	heart rate in the recovery room	1 hour after the end of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea	Nausea was graded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe.	24 hours after the end of surgery
postoperative vomiting	vomiting was graded as 0 = no, 1 = 1, 2 = 2, and 3 = 3 or more episodes	24 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Director: Hung-Te Hsu, MD/PhD, Department of anesthesiology,Kaohsiung Municipal Ta-Tung Hospital , Kaohsiung City 801，Taiwan (R.O.C.)

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 3, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: dexamethasone; Ropivacaine; supraclavicular nerve block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine
• Other Study ID Numbers: KMUHIRB-F(I)-20180034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share individual participant data.

Drug and device information, study documents

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