Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block

NCT05767827 | Completed DMC

• 1 other identifier: NepalMCTH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.

Conditions

Local Anesthesia Adjuvants; Upper Extremity Fracture; Brachial Plexus Block

Outcome Measures

Primary Outcomes (3)

• Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine

  Analgesia will be assessed with the help of Visual analogue score ( VAS). VAS greater than 3 will be given inj.ketorolac 30mg IV.

  5 months

• Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine

  Sensory block assessed by 3point scale 0 normal sensation 1. loss of sensation of pinprick 2. loss of sensation of touch Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0).Motor blockade assessed by modified Bromage scale (MBS) 0-able to raise extended arm to 90 degree for full two seconds 1. able to flex elbow, move fingers but unable to raise extended arm 2. unable to flex elbow but able to move fingers 3. unable to move arm, elbow, fingers Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).

  5 months

• Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine

  Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0). Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).

  5months

Secondary Outcomes (1)

• Assess any complications of study drugs

  5 months

Study Arms (2)

Group R

ACTIVE COMPARATOR

0.35% ropivacaine 20ml, 1.5% lidocaine with adrenaline 10ml = 30 ml

Drug: ropivacaine, lidocaine with adrenaline

Group RD

EXPERIMENTAL

0.35% ropivacaine and 1mcg/ kg dexmedetomidine (20 ml), 1.5% lidocaine with adrenaline (10ml) = 30 ml

Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline

Interventions

ropivacaine, lidocaine with adrenaline DRUG

Group R includes 0.35% ropivacaine 20ml, 1.5 % lidocaine with adrenaline 10ml

Group R

Dexmedetomidine, ropivacaine, lidocaine with adrenaline DRUG

Dexmedetomidine 1mcg/kg and 0.35% ropivacaine with normal saline (20ml), 1.5% lidocaine with adrenaline (10ml) in group RD

Group RD

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I and II patients, weight 45 to 74 kg
• Elective upper limb surgery under brachial plexus block

You may not qualify if:

• known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine
• Pregnant or lactating mothers
• Hepatic, renal or cardiopulmonary abnormalities
• Long term analgesic therapy

Sponsors & Collaborators

• Nepal Medical College and Teaching Hospital: lead

Study Sites (1)

Nepal medical college

Kathmandu, Bagmati, 0096, Nepal

Location

MeSH Terms

Interventions

Ropivacaine; Lidocaine; Epinephrine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 14, 2023
• Study Start: February 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)