Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

Sponsor
Nepal Medical College and Teaching Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767827
Collaborator
(none)
40
1
2
5.9
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ropivacaine, lidocaine with adrenaline
  • Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group R

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

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

Experimental: Group RD

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

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

Outcome Measures

Primary Outcome Measures

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

  1. Assess any complications of study drugs [5 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nepal medical college Kathmandu Bagmati Nepal 0096

Sponsors and Collaborators

  • Nepal Medical College and Teaching Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajiv Yadav, Lecturer, Nepal Medical College and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT05767827
Other Study ID Numbers:
  • NepalMCTH
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023