Nerve BlockONBNCT02066727
Lidocaine Combined Dexmedetomidine for Obturator Nerve Block
A study testing Dexmedetomidine and Normal Saline in people with Nerve Block, run by Guolin Wang at 1 site in China.
Trial summary
Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- Dexmedetomidine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
Who cannot join
- Subject has a diagnosis of abnormal coagulation function.
- Subject has a diagnosis of Diabetes mellitus.
- Subject has a preexisting neurologic deficits of the lower extremities.
- Subject has a history of alcohol or drug abuse.
- Subject is pregnant or breast-feeding.
- Subject is obese (body mass index >30kg/m2).
Trial locations and contacts
1 site in 1 country.
China1 site
Tainjin Medical University General Hospita& the Second Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: Effects of Dexmedetomidine as an Adjuvant on the Median Effective Concentration of Lidocaine for Obturator Nerve Block - A Perspective, Randomized，Blind Study
Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor
Read the detailed description
A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator nerve is stimulated directly by the electronic resector during transurethral resection of the tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the following randomized, non-crossover study, the investigators test if Dexmedetomidine as an adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor.
- Conditions
- Nerve Block
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- Dexmedetomidine, obturator nerve block, lidocaine, EC50
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
Normal SalineDrug
Normal Saline is administrated as an adjuvant of lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. Receives: Drug: Dexmedetomidine |
| Normal Saline | Placebo comparator | Normal Saline is administrated as an adjuvant of lidocaine. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Effective Concentration(EC50)
Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.
For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows.
Measured: 10min
Secondary outcomes (1)
Complication Related With Nerve Block
Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively
Measured: during operation, 0.5,24hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guolin Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Sponsor-investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, MD.PHD, Study director, Tainjin Medical University General Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066727
- Sponsor's protocol ID
- GW002
- Acronym
- ONB
- Status last verified
- Dec 2014
- First submitted
- 17 Feb 2014
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lu Y, Sun J, Zhuang X, Lv G, Li Y, Wang H, Wang G. Perineural Dexmedetomidine as an Adjuvant Reduces the Median Effective Concentration of Lidocaine for Obturator Nerve Blocking: A Double-Blinded Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158226. doi: 10.1371/journal.pone.0158226. eCollection 2016.
PubMed 27341450
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine as an Adjuvant on the Median Effective Concentration of Lidocaine for Obturator Nerve Block - A Perspective, Randomized，Blind Study
- ClinicalTrials.gov ID
- NCT02066727
- Acronym / sponsor ID
- ONB / GW002
- Conditions
- Nerve Block
- Keywords
- Dexmedetomidine, obturator nerve block, lidocaine, EC50
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guolin WangUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor
Detailed description
A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator nerve is stimulated directly by the electronic resector during transurethral resection of the tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the following randomized, non-crossover study, the investigators test if Dexmedetomidine as an adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. |
| Normal Saline | Placebo comparator | Drug: Normal SalineNormal Saline is administrated as an adjuvant of lidocaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
Key exclusion criteria (6 listed)
- Subject has a diagnosis of abnormal coagulation function.
- Subject has a diagnosis of Diabetes mellitus.
- Subject has a preexisting neurologic deficits of the lower extremities.
- Subject has a history of alcohol or drug abuse.
- Subject is pregnant or breast-feeding.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. | Drug | Dexmedetomidine |
| Normal SalineNormal Saline is administrated as an adjuvant of lidocaine. | Drug | Normal Saline |
Primary outcome
Median Effective Concentration(EC50)
Time frame: 10min
Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration. For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows.
1 secondary outcome
Complication Related With Nerve Block
Time frame: during operation, 0.5,24hour postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27341450Lu Y, Sun J, Zhuang X, Lv G, Li Y, Wang H, Wang G. Perineural Dexmedetomidine as an Adjuvant Reduces the Median Effective Concentration of Lidocaine for Obturator Nerve Blocking: A Double-Blinded Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158226. doi: 10.1371/journal.pone.0158226. eCollection 2016.
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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.
Guolin Wang, MD.PHD study director
Tainjin Medical University General Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal Saline in people with Nerve Block, run by Guolin Wang at 1 site in China.
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 3 inclusion and 6 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 22 Dec 2014. 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 China. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Effective Concentration(EC50) (time frame: 10min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066727, which also lists 1 linked publication.
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 22 Dec 2014.