Surgery to the Distal One Third of the Upper LimbNCT03265886
The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics
A study testing Warm bupivacaine at (37°c) and Bupivacaine at operating room temperature (23°c) in people with Surgery to the Distal One Third of the Upper Limb, run by Mansoura University at 1 site in Egypt.
Trial summary
Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Surgery to the Distal One Third of the Upper Limb
- What is being tested?
- Warm bupivacaine at (37°c) and Bupivacaine at operating room temperature (23°c)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 17 Sep 2018
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical class I or II
Who cannot join
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases
- Bleeding disorders
- Coagulation abnormality.
Show all 12Show fewer
- Psychiatric diseases.
- Local skin infection
- Sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Bilateral upper limb injury to be performed at the same procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.
The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.
Read the detailed description
The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.
- Being tested
- Warm bupivacaine at (37°c), Bupivacaine at operating room temperature (23°c)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm bupivacaine at (37°c)Drug
Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
Bupivacaine at operating room temperature (23°c)Drug
Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use.
| Study group | Role | What they receive |
|---|---|---|
| Warm bupivacaine at (37°c) | Experimental | Warmed bupivacaine at body temperature will be administered Receives: Drug: Warm bupivacaine at (37°c) |
| Bupivacaine at operating room temperature (23°c) | Active comparator | Bupivacaine at temperature of 23°C will be administered Receives: Drug: Bupivacaine at operating room temperature (23°c) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of sensory block
defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)
Measured: for 30 min following injection
Secondary outcomes (10)
Time to onset of motor block
defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.
Measured: For 3 hours after the injection of local anesthetic
Heart rate
Measured: For 3 hours after the injection of local anesthetic
Blood pressure
Measured: For 3 hours after the injection of local anesthetic
oxygen saturation in the peripheral blood
Measured: For 3 hours after the injection of local anesthetic
Duration of sensory block
defined as the interval between end of injection and complete end of sensory block (score=2)
Measured: For 24 hours after the injection of local anesthetic
Duration of motor block
defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.
Measured: For 24 hours after the injection of local anesthetic
The severity of postoperative pain
will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.
Measured: For 24 hours after the injection of local anesthetic
Time for first analgesic request
Time to the first receiving of rescue analgesic from the time of blockade
Measured: For 24 hours after the injection of local anesthetic
Total analgesics received
Cumulative use of rescue analgesics after performing the blockade
Measured: for 24 hrs after the injection of local anesthetic
Satisfaction Score
Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Measured: for 48 hrs after the injection of local anesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Oct 2017
- Primary completion9 Jun 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery to the Distal One Third of the Upper LimbStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Y Makharita, MD, Study chair, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265886
- Sponsor's protocol ID
- MFM-IRB, MS/17.05.143
- Status last verified
- Nov 2019
- First submitted
- 25 Aug 2017
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: do not mind sharing raw data but after its publication not before.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
- ClinicalTrials.gov ID
- NCT03265886
- Acronym / sponsor ID
- MFM-IRB, MS/17.05.143
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.
The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.
Detailed description
The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm bupivacaine at (37°c) | Experimental | Drug: Warm bupivacaine at (37°c)Warmed bupivacaine at body temperature will be administered |
| Bupivacaine at operating room temperature (23°c) | Active comparator | Drug: Bupivacaine at operating room temperature (23°c)Bupivacaine at temperature of 23°C will be administered |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical class I or II
Key exclusion criteria (12 listed)
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases
- Bleeding disorders
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 |
|---|---|---|
| Warm bupivacaine at (37°c)Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block. | Drug | Warm bupivacaine at (37°c) |
| Bupivacaine at operating room temperature (23°c)Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use. | Drug | Bupivacaine at operating room temperature (23°c) |
Primary outcome
Time to onset of sensory block
Time frame: for 30 min following injection
defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)
10 secondary outcomes
Time to onset of motor block
Time frame: For 3 hours after the injection of local anesthetic
Heart rate
Time frame: For 3 hours after the injection of local anesthetic
Blood pressure
Time frame: For 3 hours after the injection of local anesthetic
oxygen saturation in the peripheral blood
Time frame: For 3 hours after the injection of local anesthetic
Duration of sensory block
Time frame: For 24 hours after the injection of local anesthetic
Duration of motor block
Time frame: For 24 hours after the injection of local anesthetic
The severity of postoperative pain
Time frame: For 24 hours after the injection of local anesthetic
Time for first analgesic request
Time frame: For 24 hours after the injection of local anesthetic
Total analgesics received
Time frame: for 24 hrs after the injection of local anesthetic
Satisfaction Score
Time frame: for 48 hrs after the injection of local anesthetic
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 6 Nov 2019.
- Individual participant dataSharing planned: Yes. do not mind sharing raw data but after its publication not before.
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.
Mohamed Y Makharita, MD study chair
Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm bupivacaine at (37°c) and Bupivacaine at operating room temperature (23°c) in people with Surgery to the Distal One Third of the Upper Limb, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 12 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 6 Nov 2019. 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 Egypt. 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?
Time to onset of sensory block (time frame: for 30 min following injection). 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 6 Nov 2019.