NCT00403663

Brief Summary

Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and epidural. Adjusting the dose of freezing medication for body size is not as simple as giving a larger dose to a larger person. This study asks a simple, yet important question: does your body mass index (BMI) influence the amount of freezing medication needed for adequate CSE anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In patients with a higher BMI, freezing medication appears to spread farther (to a higher level) in the spinal fluid. When freezing is too high, it can cause unwanted side effects. Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it may be advisable to administer less freezing medication. In this study, we want to find the ideal dose of freezing medication for patients with a higher body mass index, and compare it to the dose found to be ideal for patients with normal body mass index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2006

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

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

November 23, 2006

Last Update Submit

July 29, 2009

Conditions

PainObesity

Keywords

Body mass indexCombined Spinal-Epidural AnesthesiaCesarean sectionObesity

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the success/failure of the block. Success meaning a sensory block level at least at T6 within 15 minutes after intrathecal injection and no requirement of any supplemental analgesic by the patient throughout the CS.

    15 minutes

Secondary Outcomes (5)

  • Upper level of sensory blockage determined by the pinprick at midaxillary line

    60 minutes

  • VAPS during surgery

    60 minutes

  • Dose of lidocaine 2% required as supplementation

    60 minutes

  • Dose of IV fentanyl or ketamine required as supplementation

    60 minutes

  • Conversion to general anesthesia

    60 minutes

Interventions

bupivacaine 0.75% with fentanyl and morphineDRUG

the following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese group: All pregnant women at term (over 37 weeks) scheduled for elective Cesarean section, with pre-pregnancy BMI greater than 30
  • Normal weight group: All pregnant women at term (over 37 weeks) scheduled for elective Cesarean section, with pre-pregnancy BMI less than 25.

You may not qualify if:

  • Patient's refusal.
  • Patients with any absolute or relative contraindication for spinal/epidural anesthesia.
  • Patients with BMI between 25 and 30.
  • Patients with more than one fetus.
  • Patients unable to communicate in English effectively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

PainObesity

Interventions

BupivacaineFentanylMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Jose CA Carvalho, MD PhD

    Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2006

First Posted

November 27, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations

CA(1)