Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

Brachial Plexus Block Clinical Trial

Official title:

Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767827
• Other study ID #: NepalMCTH
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brachial Plexus Block
• Upper Extremity Fracture

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