Clinical trial NCT02066727: Lidocaine Combined Dexmedetomidine for Obturator Nerve Block
Official title: Effects of Dexmedetomidine as an Adjuvant on the Median Effective Concentration of Lidocaine for Obturator Nerve Block - A Perspective, Randomized，Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Keywords: Dexmedetomidine
obturator nerve block
lidocaine
EC50
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2014-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of abnormal coagulation function.
2. Subject has a diagnosis of Diabetes mellitus.
3. Subject has a preexisting neurologic deficits of the lower extremities.
4. Subject has a history of alcohol or drug abuse.
5. Subject is pregnant or breast-feeding.
6. Subject is obese (body mass index \>30kg/m2).

Primary outcomes:
measure: Median Effective Concentration(EC50)
timeFrame: 10min
Secondary outcomes:
measure: Complication Related With Nerve Block
timeFrame: during operation, 0.5,24hour postoperatively
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tainjin Medical University General Hospita& the Second Hospital
state: Tianjin
Study officials:
affiliation: Tainjin Medical University General Hospita
name: Guolin Wang, MD.PHD
role: STUDY_DIRECTOR
References:
citation: 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.