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Completed

NCT Number: NCT05767827

Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nepal medical college

Kathmandu, Bagmati, 0096, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ropivacaine, lidocaine with adrenaline

Drug

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

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

Primary outcomes

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

    Time frame: 5 months

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

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

    Time frame: 5 months

    Sensory block assessed by 3point scale

    0 normal sensation

    • loss of sensation of pinprick
    • 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

    • able to flex elbow, move fingers but unable to raise extended arm
    • unable to flex elbow but able to move fingers
    • 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).
  3. Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine

    Time frame: 5months

    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).

Secondary outcomes

  1. Assess any complications of study drugs

    Time frame: 5 months

    Complications like bradycardia assessed by continue ECG monitoring, Hypotension will be assessed by NIBP

Sponsors and collaborators

Lead sponsor

Nepal Medical College and Teaching Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 14, 2023
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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