Observation of Neuromuscular BlockNCT01349751
Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
A study testing isobaric levobupivacaine and hyperbaric levobupivacaine in people with Observation of Neuromuscular Block and Disease (or Disorder); Gynecological, run by Mahidol University at 1 site in Thailand.
Trial summary
The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Observation of Neuromuscular Block, Disease (or Disorder); Gynecological
- What is being tested?
- isobaric levobupivacaine and hyperbaric levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Feb 2008
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy
Who cannot join
- contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.
Read the detailed description
The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.
- Being tested
- isobaric levobupivacaine, hyperbaric levobupivacaine
- Keywords
- abdominal incision, hyperbaric, isobaric, levobupivacaine, spinal anaesthesia
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isobaric levobupivacaineDrug
Also called Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
0.42% either isobaric levobupivacaine 3 ml spinal injection once
hyperbaric levobupivacaineDrug
Also called Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
0.42% hyperbaric levobupivacaine 3 ml spinal injection once
| Study group | Role | What they receive |
|---|---|---|
| isobaric levobupivacaine | Active comparator | spinal isobaric levobupivacaine Receives: Drug: isobaric levobupivacaine |
| hyperbaric levobupivacaine | Active comparator | hyperbaric levobupivacaine Receives: Drug: hyperbaric levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to T4-dermatome sensory blockade
to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery
Measured: 30 minutes
Secondary outcomes (1)
side effects
to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery
Measured: 1 to 4 hours intraoperation plus within 2 hours in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observation of Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vimolluck Sanansilp, Mahidol University
- Investigators
- Vimolluck - Sanansilp, MD, Principal investigator, Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349751
- Sponsor's protocol ID
- SiEC 197/2549
- Status last verified
- Nov 2013
- First submitted
- 5 May 2011
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
- ClinicalTrials.gov ID
- NCT01349751
- Acronym / sponsor ID
- SiEC 197/2549
- Keywords
- abdominal incision, hyperbaric, isobaric, levobupivacaine, spinal anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 9 May 2011 (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.
The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.
Detailed description
The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isobaric levobupivacaine | Active comparator | Drug: isobaric levobupivacainespinal isobaric levobupivacaine |
| hyperbaric levobupivacaine | Active comparator | Drug: hyperbaric levobupivacainehyperbaric levobupivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy
Key exclusion criteria (1 listed)
- contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm
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 |
|---|---|---|
| isobaric levobupivacaineAlso: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway0.42% either isobaric levobupivacaine 3 ml spinal injection once | Drug | isobaric levobupivacaine |
| hyperbaric levobupivacaineAlso: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway0.42% hyperbaric levobupivacaine 3 ml spinal injection once | Drug | hyperbaric levobupivacaine |
Primary outcome
time to T4-dermatome sensory blockade
Time frame: 30 minutes
to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery
1 secondary outcome
side effects
Time frame: 1 to 4 hours intraoperation plus within 2 hours in the recovery room
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 7 Nov 2013.
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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.
Vimolluck - Sanansilp, MD principal investigator
Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isobaric levobupivacaine and hyperbaric levobupivacaine in people with Observation of Neuromuscular Block and Disease (or Disorder); Gynecological, run by Mahidol University at 1 site in Thailand.
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 1 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 7 Nov 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 Thailand. 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 T4-dermatome sensory blockade (time frame: 30 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 7 Nov 2013.