Predictive Value of Ultrasound Measurement of the Dural Sac Volume on the Sensory Level in Spinal Anesthesia

NCT01624844 | Completed

• 1 other identifier: SG 2012-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether the dural sac volume as determined by a geometrical calculation following multilevel measurements of its transverse area and length by ultrasound imaging, correlates with the intrathecal spread of a single dose of hyperbaric bupivacaine in a non-obstetrical population.

Conditions

Spinal Anesthesia

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

• Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging

  Before spinal anesthesia (Day 0)

Secondary Outcomes (6)

• Peak sensory level

  From injection of bupivacaine until 30 minutes after injection (Day 0)

• Time spent for ultrasound imaging measurements

  Before spinal anesthesia (Day 0)

• Duration of motor block

  At 3.5, 4 and 4.5 hours following injection of bupivacaine (Day 0)

• Incidence of side-effects related to spinal anesthesia

  From spinal injection of bupivacaine until discharge from the hospital (Patients will be followed for the duration of hospital stay, an expected average of 3 days)

• Length of stay in the recovery room

  From arrival to discharge from the recovery room (Patients will be followed for the duration of stay in the recovery room on the day of surgery, an expected average of one hour)

Study Arms (1)

Calculation of dural sac volume

EXPERIMENTAL

Other: Geometrical calculation of dural sac volume

Interventions

Geometrical calculation of dural sac volume OTHER

Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging before spinal anesthesia

Calculation of dural sac volume

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients aged 18-80 years
• ASA physical status 1-3

You may not qualify if:

• Contraindication to regional anesthesia (coagulopathy, sepsis or local infection at the site of injection, pre-existing neuropathy in the area involved)
• Surgery requiring the use of isobaric bupivacaine (0.5%)
• Allergy to local anesthetics (amide group)
• Anatomic abnormality of the spine (scoliosis, kyphosis)
• Previous spinal surgery
• Patient refusal

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

• Sébastien Garneau, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 21, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

CA (1)