Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

N/ACompletedNCT02066727

Guolin Wang60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Nerve Block

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (1)

Tainjin Medical University General Hospita& the Second Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 10min

Secondary Outcomes

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

Time frame: during operation, 0.5,24hour postoperatively

Data from ClinicalTrials.gov

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