Comparison of Onset TimeNCT01815944
Onset Time of Brachial Plexus Block Using Local Anaesthetic Diluted With 0.9% Saline vs 5% Dextrose
A study testing 0.75% Ropivacaine, Normal saline and Dextrose 5% in people with Comparison of Onset Time, run by University of Malaya at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Comparison of Onset Time
- What is being tested?
- 0.75% Ropivacaine, Normal saline and Dextrose 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I to III
- elective or emergency surgery of the hand, forearm and elbow
Who cannot join
- diabetes mellitus
- neurological deficit
- contraindications to supraclavicular brachial plexus blockade
- unable to give consent
- patient refusal
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
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
Read the detailed description
- 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.
- Conditions
- Comparison of Onset Time
- Being tested
- 0.75% Ropivacaine, Normal saline, Dextrose 5%
- Keywords
- onset time, ultrasound-guided supraclavicular block, ropivacaine, normal saline, dextrose 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% RopivacaineDrug
Also called Naropin
Normal salineDrug
Dextrose 5%Drug
| Study group | Role | What they receive |
|---|---|---|
| 0.75% Ropivacaine and normal saline | Active comparator | Ultrasound-guided supraclavicular block using 0.75% ropivacaine diluted with normal saline Receives: 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% Receives: Drug: 0.75% Ropivacaine; Drug: Dextrose 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time for sensory blockade
Measured: 60 minutes
Secondary outcomes (1)
Duration of sensory blockade
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Onset TimeStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mohd Shahnaz, University of Malaya
- Investigators
- M. Shahnaz Hasan, MBBS, M Anes, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815944
- Sponsor's protocol ID
- UMMC883.11
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset Time of Brachial Plexus Block Using Local Anaesthetic Diluted With 0.9% Saline vs 5% Dextrose
- ClinicalTrials.gov ID
- NCT01815944
- Acronym / sponsor ID
- UMMC883.11
- Conditions
- Comparison of Onset Time
- Keywords
- onset time, ultrasound-guided supraclavicular block, ropivacaine, normal saline, dextrose 5%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.75% Ropivacaine and normal saline | Active comparator | Drug: 0.75% Ropivacaine, Drug: Normal salineUltrasound-guided supraclavicular block using 0.75% ropivacaine diluted with normal saline |
| 0.75% ropivacaine and dextrose 5% | Experimental | Drug: 0.75% Ropivacaine, Drug: Dextrose 5%Ultrasound guided supraclavicular block using 0.75% ropivacaine diluted with dextrose 5% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I to III
- elective or emergency surgery of the hand, forearm and elbow
Key exclusion criteria (5 listed)
- diabetes mellitus
- neurological deficit
- contraindications to supraclavicular brachial plexus blockade
- unable to give consent
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.75% RopivacaineAlso: Naropin | Drug | 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% |
Primary outcome
Onset time for sensory blockade
Time frame: 60 minutes
1 secondary outcome
Duration of sensory blockade
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Shahnaz Hasan, MBBS, M Anes principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.75% Ropivacaine, Normal saline and Dextrose 5% in people with Comparison of Onset Time, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time for sensory blockade (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013; AzTrials last refreshed its copy on 6 Nov 2026.