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临床试验/NCT01548794
NCT01548794已完成4 期

A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy

Diskapi Teaching and Research Hospital2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
93
试验地点
2
主要终点
Duration of spinal block

研究概览

简要总结

The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.

详细描述

Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having inguinal hernia
  • Not hypersensitive to study drugs
  • ASA classification I-III

排除标准

  • ASA classification IV-V
  • Contraindications for spinal anesthesia

结局指标

主要结局

Duration of spinal block

时间窗: day of surgery

Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.

次要结局

  • Discharge time(Day of surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DILEK YAZICIOGLU

Doctor Specialist in Anesthesiology Principal investigator

Diskapi Teaching and Research Hospital

研究点 (2)

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