Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01349751

Enrollment

Registered

2011-05-09

Start date

2007-01-31

Completion date

2008-02-29

Last updated

2013-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease (or Disorder); Gynecological, Observation of Neuromuscular Block

Keywords

abdominal incision, hyperbaric, isobaric, levobupivacaine, spinal anaesthesia

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.

Interventions

DRUGisobaric levobupivacaine

0.42% either isobaric levobupivacaine 3 ml spinal injection once

DRUGhyperbaric levobupivacaine

0.42% hyperbaric levobupivacaine 3 ml spinal injection once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026