Supraclavicular Brachial Plexus Block Using Ropivacaine Alone and With Dexmedetomidine

NCT02393677 | Completed Results

• 1 other identifier: DN57/FM
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

80 American Society of Anesthesiologists (ASA) grade I-II patients, 18-60 years old,scheduled for elective upper limb orthopaedic surgery under supraclavicular brachial plexus block, were included in this prospective study. The patients were randomly assigned to group R (Ropivacaine alone) and group RD (Ropivacaine and dexmedetomidine) (40 patients in each group). Group R received Ropivacaine 0.50% (30 cc) + placebo and group RD received Ropivacaine 0.50% (30 cc) + dexmedetomidine 1 µg/kg.

Conditions

Brachial Plexus Anesthesia

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  upto 8 hours

Secondary Outcomes (3)

• Onset of Sensory Block

  20 minutes

• Onset of Motor Block

  30minutes

• Duration of Motor Block

  6 hours

Other Outcomes (2)

• Haemodynamic Changes

  8 hours

• Complications

  2 hours

Study Arms (2)

Ropivacaine

PLACEBO COMPARATOR

amide local anesthetic

Drug: Ropivacaine

Ropivacaine with Dexmedetomidine

ACTIVE COMPARATOR

combination of amide local anaesthetic and alpha2 agonist

Drug: Ropivacaine with Dexmedetomidine

Interventions

Ropivacaine DRUG

Ropivacaine 0.5% 30 ml was used to block brachial plexus

Also known as: Ropin

Ropivacaine

Ropivacaine with Dexmedetomidine DRUG

Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus

Also known as: Ropin with Dextomid

Ropivacaine with Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA Grade I and II patients of either sex, aged 18-60 years, undergoing various orthopaedic surgeries on the upper limb under supraclavicular brachial plexus block.

You may not qualify if:

• Patient refusal
• Patients with chronic pain (pain lasting more than 12 weeks)
• Those using chronic analgesic medications (opioid, non steroidal anti-inflammatory drugs, anticonvulsants, antidepressants)
• Coagulopathy
• History of brachial plexus injury
• Allergy to the study drugs
• Patients taking other medications with α-adrenergic blocking effect
• Hepatic or renal insufficiency
• Systemic infection or infection at the site of injection, and shoulder surgery.

Sponsors & Collaborators

• Government Medical College, Haldwani: lead

MeSH Terms

Interventions

Ropivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Bikramjit Das
• Organization: Govt. Medical College, Haldwani.

bikramjit_81@rediff.com

(05946)-228393

Study Officials

• Shahin N Jamil, MD

  Professor, Aligarh Muslim University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 19, 2015
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 6, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-10