NCT01349751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

May 5, 2011

Last Update Submit

November 5, 2013

Conditions

Observation of Neuromuscular BlockDisease (or Disorder); Gynecological

Keywords

abdominal incisionhyperbaricisobariclevobupivacainespinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • time to T4-dermatome sensory blockade

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

    30 minutes

Secondary Outcomes (1)

  • side effects

    1 to 4 hours intraoperation plus within 2 hours in the recovery room

Study Arms (2)

isobaric levobupivacaine

ACTIVE COMPARATOR

spinal isobaric levobupivacaine

Drug: isobaric levobupivacaine

hyperbaric levobupivacaine

ACTIVE COMPARATOR

hyperbaric levobupivacaine

Drug: hyperbaric levobupivacaine

Interventions

isobaric levobupivacaineDRUG

0.42% either isobaric levobupivacaine 3 ml spinal injection once

Also known as: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
isobaric levobupivacaine
hyperbaric levobupivacaineDRUG

0.42% hyperbaric levobupivacaine 3 ml spinal injection once

Also known as: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
hyperbaric levobupivacaine

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Disease

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Vimolluck - Sanansilp, MD

    Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2011

First Posted

May 9, 2011

Study Start

January 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

TH(1)