Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

Nerve Block Clinical Trial

— ONB  

Official title:

Effects of Dexmedetomidine as an Adjuvant on the Median Effective Concentration of Lidocaine for Obturator Nerve Block — A Perspective, Randomized，Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066727
• Other study ID #: GW002
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: December 11, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Block

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
China	Tainjin Medical University General Hospita& the Second Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Guolin Wang	Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10min	Yes
Secondary	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	during operation, 0.5,24hour postoperatively	Yes