Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05767827
Other study ID # NepalMCTH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date July 30, 2023

Study information

Verified date March 2023
Source Nepal Medical College and Teaching Hospital
Contact Rajiv Yadav, MD ANESTHESIA
Phone 9816826324
Email munnaraj2042@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Nepal Nepal medical college Kathmandu Bagmati

Sponsors (1)

Lead Sponsor Collaborator
Nepal Medical College and Teaching Hospital

Country where clinical trial is conducted

Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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).
5 months
Primary 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 Assess any complications of study drugs Complications like bradycardia assessed by continue ECG monitoring, Hypotension will be assessed by NIBP 5 months
See also
  Status Clinical Trial Phase
Withdrawn NCT04053491 - Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block. N/A
Completed NCT03211949 - Ultrasound Guided Topographic Mapping of Medial Antebrachial Cutaneous Nerve N/A
Suspended NCT03291691 - Protective Nerve Stimulation in Regional Anesthesia
Completed NCT03270033 - Intravenous Dexmedetomidine, Dexamethasone and Interscalene Block Duration After Arthroscopic Shoulder Surgery Phase 4
Recruiting NCT06015204 - Assessment of the C8 Dermatomal Block With Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block N/A
Not yet recruiting NCT03279679 - Comparison Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery N/A
Completed NCT02305875 - The Musculocutaneous Nerve in a High Resolution MRI N/A
Completed NCT03688724 - Perioperative Diaphragm Point of Care Ultrasound
Completed NCT05005260 - Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty Phase 4
Completed NCT02462408 - Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block N/A
Completed NCT02312453 - Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block N/A
Completed NCT00321425 - Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block N/A
Recruiting NCT03577860 - Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block N/A
Completed NCT04356521 - Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block N/A
Completed NCT04463329 - Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block N/A
Not yet recruiting NCT04784104 - Comparison of Infraclavicular And Supraclavicular Block Phase 4
Terminated NCT03785392 - Out of Plane Approach for Interscalene N/A
Completed NCT02787018 - Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block Phase 3
Completed NCT03514342 - The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
Completed NCT05315271 - Supraclavicular Brachial Plexus Block During Upper Limb Surgeries Early Phase 1