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The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609517
First Posted: June 1, 2012
Last Update Posted: October 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
  Purpose
In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal anesthetic outcome by logistic regression analysis.

Condition Intervention
Spinal Anesthesia Success or Failure of Spinal Anesthesia Drug: Spinal anesthesia (heavy bupivacaine)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty

Resource links provided by NLM:


Further study details as provided by Sangmin M. Lee, Samsung Medical Center:

Primary Outcome Measures:
  • spinal anesthetic success/ failure [ Time Frame: at 2 hour after the anesthetic induction ]
    when (1) a bilateral T12 sensory block to pinprick within 15 minutes of intrathecal drug administration with sensory/motor block scale ≥ 2 and (2) the level of sensory block at the end of surgery was higher than or equal to T12 with sensory/motor block scale ≥ 2.


Secondary Outcome Measures:
  • Peak level of sensory block at anesthesia induction [ Time Frame: during 20 min after anesthetic induction ]
    Sensory block levels determined by pinprick test

  • Spinal anesthesia sensory/motor block level at the end of surgery [ Time Frame: 2 hours after induction (at the end of surgery) ]

    Spinal anesthesia block level as determined by Pinprick sensory test with Bromage scale.

    Sensory 0 = an ability to appreciate a pinprick as sharp; 1 = perception of a pinprick as less sharp than in unblocked areas; 2 = perception of a pinprick as touch but not sharp (analgesia); 3 = an inability to feel pinprick(anesthesia).

    Bromage Scale 0 = ability to lift an extended knee at the hip; 1 = ability to flex the knee but not to lift an extended leg; 2 = ability to flex toes only; 3 = inability to move.


  • the incidence of tourniquet pain [ Time Frame: at 90 min afer anesthetic induction ]
    the incidence of tourniquet pain during the tourniquet time reported by the patient (NRS >= 2)

  • Incidence of hypotension, bradycardia [ Time Frame: during 2 hours after anesthesia induction ]
    Incidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering


Enrollment: 209
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese group
patients with BMI >= 30.0 kg/m2 who received spinal anesthesia with heavy marcaine
Drug: Spinal anesthesia (heavy bupivacaine)
Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg
Other Names:
  • Spinal anesthesia
  • heavy bupivacaine
Non-obese group
patients with BMI < 30.0 kg/m2 who received spinal anesthesia with heavy marcaine
Drug: Spinal anesthesia (heavy bupivacaine)
Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg
Other Names:
  • Spinal anesthesia
  • heavy bupivacaine

Detailed Description:

Although the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia is controversial, and there is no specific guideline showing the relative priority of these determinants.

Therefore, in these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
Criteria

Inclusion Criteria:

  • Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
  • American Society of Anesthesiologist Physical Status classification I ~ III

Exclusion Criteria:

  • Bupivacaine allergy
  • medical history of spinal surgery
  • Diabetic neuropathy
  • active infection at the lumbosacral area
  • other contraindication of spinal anesthesia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609517


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sangmin M. Lee, MD, PhD Samsung Medical Center
Principal Investigator: Ji Sun Hahm, MD Samsung Medical Center
  More Information

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01609517     History of Changes
Other Study ID Numbers: 2012-04-089-001
First Submitted: May 29, 2012
First Posted: June 1, 2012
Last Update Posted: October 30, 2014
Last Verified: October 2014

Keywords provided by Sangmin M. Lee, Samsung Medical Center:
Spinal anesthesia
determinant
duration

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents