Dexamethasone at Lower Concentration Ropivacaine in the Supraclavicular Nerve Block

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03572686
• Other study ID #: KMUHIRB-F(I)-20180034
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Brachial Plexus Block
• Motor Activity

Intervention

Drug:
• Ropivacaine 0.5% 20mL
In Group RH, participants received supraclavicular brachial plexus block with ropivacaine 0.5% 20ml at the end of surgery.
• Ropivacaine 0.25% 20ml
In Group RL, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml at the end of surgery.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hosptial	Kaohsiung City
Taiwan	Kaohsiung Municipal Ta-Tung Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative nausea	Nausea was graded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe.	24 hours after the end of surgery
Other	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
Primary	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	blood pressure	systolic, diastolic, and mean blood pressure in the recovery room	1 hour after the end of surgery
Secondary	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
Secondary	heart rate	heart rate in the recovery room	1 hour after the end of surgery