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Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

NCT ID: NCT02066727

Last Updated: 2014-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

Brief Summary

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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

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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

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Nerve Block

Keywords

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Dexmedetomidine obturator nerve block lidocaine EC50

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine

Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.

Normal Saline

Normal Saline is administrated as an adjuvant of lidocaine.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal Saline is administrated as an adjuvant of lidocaine.

Interventions

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Dexmedetomidine

Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.

Intervention Type DRUG

Normal Saline

Normal Saline is administrated as an adjuvant of lidocaine.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Guolin Wang

OTHER

Sponsor Role lead

Responsible Party

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Guolin Wang

Tianjin Medical University General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guolin Wang, MD.PHD

Role: STUDY_DIRECTOR

Tainjin Medical University General Hospita

Locations

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Tainjin Medical University General Hospita& the Second Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 27341450 (View on PubMed)

Other Identifiers

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GW002

Identifier Type: -

Identifier Source: org_study_id