Onset Time of Brachial Plexus Block Using Local Anaesthetic Diluted With 0.9% Saline vs 5% Dextrose

NCT01815944 | Completed DMC

• 1 other identifier: UMMC883.11
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Regional anesthesia employs the use of local anesthetics (LA) to block specific nerves to enable pain free surgery to be performed, or for intra and post operative pain relief. Dilution of local anesthetics with normal saline (NS) is a common practice to enable larger volumes of LA to be given, for example, in instances where multiple nerve blocks are needed to be performed for optimal pain relief while avoiding toxic doses. A high sodium concentration is known to antagonize the analgesic effect of local anesthetics. 5% dextrose (D5W) on the other hand is painless on injection and does not cause any long-term effects in animals or humans when injected around neurological tissue. In the literature, only one study using dextrose 5% as diluent to produce 0.5% ropivacaine for axillary brachial plexus block showed a statistically significant reduction in the onset time for sensory blockade when compared with dilution with NS. In this study, 0.5% ropivacaine diluted with D5W or NS is used for ultrasound guided supraclavicular brachial plexus block, and the time for complete sensory and motor blockade was compared. 0.5% ropivacaine is easily diluted and is a common concentration used at our centre for nerve blocks. The aim of this study is to assess if 0.5% ropivacaine diluted with D5W results in a shorter onset time for sensory block which may change the current practice of dilution with NS

Conditions

Comparison of Onset Time

Keywords

onset time; ultrasound-guided supraclavicular block; ropivacaine; normal saline; dextrose 5%

Outcome Measures

Primary Outcomes (1)

• Onset time for sensory blockade

  60 minutes

Secondary Outcomes (1)

• Duration of sensory blockade

  12 hours

Study Arms (2)

0.75% Ropivacaine and normal saline

ACTIVE COMPARATOR

Ultrasound-guided supraclavicular block using 0.75% ropivacaine diluted with normal saline

Drug: 0.75% Ropivacaine; Drug: Normal saline

0.75% ropivacaine and dextrose 5%

EXPERIMENTAL

Ultrasound guided supraclavicular block using 0.75% ropivacaine diluted with dextrose 5%

Drug: 0.75% Ropivacaine; Drug: Dextrose 5%

Interventions

0.75% Ropivacaine DRUG

Also known as: Naropin

0.75% Ropivacaine and normal saline; 0.75% ropivacaine and dextrose 5%

Normal saline DRUG

0.75% Ropivacaine and normal saline

Dextrose 5% DRUG

0.75% ropivacaine and dextrose 5%

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to III
• elective or emergency surgery of the hand, forearm and elbow

You may not qualify if:

• diabetes mellitus
• neurological deficit
• contraindications to supraclavicular brachial plexus blockade
• unable to give consent
• patient refusal

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• M. Shahnaz Hasan, MBBS, M Anes

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

MY (1)