Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02787018
• Date of registration: 14/05/2016
• Prospective Registration: Yes
• Primary sponsor: B.P. Koirala Institute of Health Sciences
• Public title: Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
• Scientific title: Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block
• Date of first enrolment: June 2016
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02787018
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Nepal

Contacts

• Name: Parineeta Thapa, MD
• Affiliation: BPKIHS, Dharan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients of American Society of Anesthesiologists Physical Status I and II undergoing
elective upper limb surgery under supraclavicular brachial plexus block

Exclusion Criteria:

- Patient's refusal to participate

- Patients weighing less than 40 kg

- Allergy to study drugs

- Infection at the site of injection

- Patients with preexisting neurological deficit

- Patients with diabetes mellitus

- Patients on steroids preoperatively

- Patients with bleeding disorder or coagulopathy

- Abnormalities in ECG like AV block or symptomatic bradycardia

- Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively

- Requirement of conversion to general anesthesia due to inadequate block



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Brachial Plexus Block

Intervention(s)

Drug: Ropivacaine and Dexamethasone

Drug: Ropivacaine and Dexmedetomidine

Drug: Ropivacaine and Normal saline

Primary Outcome(s)

Onset of sensory block [Time Frame: every 3 minutes until 45 minutes after injection of drug]

Duration of analgesia [Time Frame: Up to 24 hours after onset of block]

Onset of motor block [Time Frame: every 3 minutes until 45 minutes after injection of drug]

Secondary Outcome(s)

Incidence of side effects of drugs [Time Frame: Forty-eight hours following the injection of local anesthetics]

Duration of motor block [Time Frame: Up to 24 hours after onset of block]

Duration of sensory block [Time Frame: Up to 24 hours after onset of block]

Secondary ID(s)

IRC/641/015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors