Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Observation of Neuromuscular Block Clinical Trial

Official title:

Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349751
• Other study ID #: SiEC 197/2549
• Status: Completed
• Phase: N/A
• First received: May 5, 2011
• Last updated: November 5, 2013
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

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

Intervention

Drug:
• isobaric levobupivacaine
0.42% either isobaric levobupivacaine 3 ml spinal injection once
• hyperbaric levobupivacaine
0.42% hyperbaric levobupivacaine 3 ml spinal injection once

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to T4-dermatome sensory blockade	to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery	30 minutes	No
Secondary	side effects	to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery	1 to 4 hours intraoperation plus within 2 hours in the recovery room	Yes