Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

Brachial Plexus Block Clinical Trial

Official title:

Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787018
• Other study ID #: IRC/641/015
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Description:

Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block

Exclusion Criteria:

• Patient's refusal to participate

• Patients weighing less than 40 kg

• Allergy to study drugs

• Infection at the site of injection

• Patients with preexisting neurological deficit

• Patients with diabetes mellitus

• Patients on steroids preoperatively

• Patients with bleeding disorder or coagulopathy

• Abnormalities in ECG like AV block or symptomatic bradycardia

• Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively

• Requirement of conversion to general anesthesia due to inadequate block

Related Conditions & MeSH terms

• Brachial Plexus Block

Intervention

Drug:
• Ropivacaine and Normal saline
Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline
• Ropivacaine and Dexamethasone
Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone
• Ropivacaine and Dexmedetomidine
Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine

Locations

Country	Name	City	State
Nepal	B. P. Koirala Institute of Health Sciences	Dharan Bazar	Koshi

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (4)

Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10. Review. — View Citation

Das A, Majumdar S, Halder S, Chattopadhyay S, Pal S, Kundu R, Mandal SK, Chattopadhyay S. Effect of dexmedetomidine as adjuvant in ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded and randomized controlled study. Saudi J Anaesth. 2014 Nov;8(Suppl 1):S72-7. doi: 10.4103/1658-354X.144082. — View Citation

Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014 May-Aug;8(2):202-8. doi: 10.4103/0259-1162.134506. — View Citation

Zhang Y, Wang CS, Shi JH, Sun B, Liu SJ, Li P, Li EY. Perineural administration of dexmedetomidine in combination with ropivacaine prolongs axillary brachial plexus block. Int J Clin Exp Med. 2014 Mar 15;7(3):680-5. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of sensory block	Sensory block in the territories of median nerve (palmar surface of index finger), ulnar nerve (palmar surface of little finger), radial nerve (dorsal surface of first web space/ thumb) and musculocutaneous nerve (lateral side of volar surface of forearm) will be assessed by pinprick test using a 3-point scale: 0 - normal sensation,; - loss of sensation of pinprick (analgesia),; - loss of sensation of touch (anaesthesia). Complete sensory block will be defined as grade 2 sensory block in 3 or more nerve territories.	every 3 minutes until 45 minutes after injection of drug
Primary	Onset of motor block	Motor block will be evaluated by thumb flexion/ opposition (median nerve), thumb extension (radial nerve), finger abduction (ulnar nerve) and elbow flexion with forearm in full supination (musculocutaneous nerve) on a 3-point scale for motor function: 0 - normal motor function,; - reduced motor strength but able to move,; - complete motor block. Complete motor block will be defined as grade 2 motor block in 3 or more nerve territories.	every 3 minutes until 45 minutes after injection of drug
Primary	Duration of analgesia		Up to 24 hours after onset of block
Secondary	Duration of sensory block	time from onset of sensory block to complete recovery of anaesthesia on all nerves.	Up to 24 hours after onset of block
Secondary	Duration of motor block	time from onset of motor block to the recovery of complete motor function of the hand and forearm	Up to 24 hours after onset of block
Secondary	Incidence of side effects of drugs	Side effects like bradycardia, tachycardia, hypotension, sedation, neurological deficit will be evaluated	Forty-eight hours following the injection of local anesthetics