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Completed

NCT Number: NCT02066727

Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tainjin Medical University General Hospita& the Second Hospital

Tianjin, Tianjin Municipality, 300000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Dexmedetomidine

Drug

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

normal saline

Drug

Normal Saline is administrated as an adjuvant of lidocaine.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complication Related With Nerve Block

    Time frame: during operation, 0.5,24hour postoperatively

    Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively

Sponsors and collaborators

Lead sponsor

Guolin Wang

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Official study title

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

Acronym: ONB

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Dec 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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