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Completed

NCT Number: NCT01349751

Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

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.

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Key information

Conditions

Observation of Neuromuscular Block Disease Disease (or Disorder); Gynecological Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

isobaric levobupivacaine

Drug

0.42% either isobaric levobupivacaine 3 ml spinal injection once

Other names: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway

hyperbaric levobupivacaine

Drug

0.42% hyperbaric levobupivacaine 3 ml spinal injection once

Other names: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway

Primary outcomes

  1. time to T4-dermatome sensory blockade

    Time frame: 30 minutes

    to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery

Secondary outcomes

  1. side effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 9, 2011
Registry last updated
Nov 7, 2013

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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