Completed

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

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What is being tested

0.75% Ropivacaine

+ Normal saline

+ 0.75% Ropivacaine

Drug
Who is being recruted

From 18 to 85 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2011
See protocol details

Summary

Principal SponsorUniversity of Malaya
Last updated: March 21, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2011

Actual date on which the first participant was enrolled.

Patients randomly assigned to receive either 0.5% ropivacaine diluted with NS or D5W. Randomization followed a computer-generated randomization table and patients are blinded as to their group allocation. Group allocations are concealed in a sealed opaque envelope and only known to an independent anaesthesia trainee who prepares 20mls 0.5% ropivacaine The anaesthesiologist involved in the performance of the supraclavicular brachial plexus block is blinded to group allocation All ultrasound-guided supraclavicular blocks are performed by 2 anaesthesiologists who are familiar with the technique. A trained anaesthesiology trainee who is blinded to group allocation evaluated sensory loss and motor blockade every 5 mins after injection of local anaesthetic. The extent of sensory loss is tested in the median, radial, ulnar, and musculocutaneous nerve distributions and evaluated using a 3-point score: 2 = normal sensation, 1 =loss of sensation to pinprick (ie, analgesia), or 0 = loss of sensation to light touch (ie, anesthesia). The extent of motor blockade is tested in the distribution of the radial (thumb abduction), ulnar (thumb adduction), musculocutaneous (flexion of the elbow in supination and pronation), and median nerves (thumb opposition) and evaluated using a 3-point scale where 2 = normal movement, 1 = paresis, and 0 = absent movement. Block success is defined as loss of sensation to pinprick (sensory score 1) in each of the radial, ulnar, median, and musculocutaneous nerve distributions measured 60 mins after the end of local anaesthetic injection. Patients in whom block success was not achieved after 60 mins were excluded from data analysis. During the postoperative recovery period, pain (verbal response score 4 or patient request for analgesic) is treated with IV tramadol 25-50 mg slow bolus with or without fentanyl 25mcg boluses every 5 minutes as needed. When oral intake is allowed, patients will receive oral paracetamol 1g with oral diclofenac 50 mg or celecoxib 200mg, if not contraindicated. The block duration is subsequently taken as time from complete analgesia to the time when the patient first feels the slightest pain from the operative site. Patients are followed up twice; once on post-operative day (POD) 1 and once between POD 7-10. They are seen in the ward or are contacted via telephone and asked for the presence of any pain, weakness, numbness, tingling, or any abnormal sensation in the operative extremity. If indicated, they are then told to come to hospital for further evaluation and management as necessary.

Principal SponsorUniversity of Malaya
Last updated: March 21, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

55 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
ASA I to III

elective or emergency surgery of the hand, forearm and elbow

5 exclusion criteria prevent from participating
contraindications to supraclavicular brachial plexus blockade

diabetes mellitus

neurological deficit

patient refusal

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Malaya Medical Centre

Kuala Lumpur, MalaysiaOpen University Malaya Medical Centre in Google Maps
CompletedOne Study Center