Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Not Applicable

Completed

• Conditions: Disease (or Disorder); Gynecological; Observation of Neuromuscular Block
• Interventions: Drug: isobaric levobupivacaine; Drug: hyperbaric levobupivacaine

• Registration Number: NCT01349751
• Lead Sponsor: Mahidol University

Brief Summary

The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.

Detailed Description

The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy

Exclusion Criteria

• contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isobaric levobupivacaine	isobaric levobupivacaine	spinal isobaric levobupivacaine
hyperbaric levobupivacaine	hyperbaric levobupivacaine	hyperbaric levobupivacaine

Primary Outcome Measures

Name	Time	Method
time to T4-dermatome sensory blockade	30 minutes	to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery

Secondary Outcome Measures

Name	Time	Method
side effects	1 to 4 hours intraoperation plus within 2 hours in the recovery room	to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand