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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01609517
First received: May 29, 2012
Last updated: July 20, 2014
Last verified: July 2014
  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 Samsung Medical Center:

Primary Outcome Measures:
  • spinal anesthetic success/ failure [ Time Frame: at 2 hour after the anesthetic induction ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Incidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering


Estimated Enrollment: 209
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609517

Contacts
Contact: Sangmin M. Lee, MD, PhD 82-2-3410-0362 sangminm.lee@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-2470 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sangmin M. Lee, MD, PhD    82-2-3410-2470    sangminm.lee@samsung.com   
Contact: Won Ho Kim, MD    82-2-3410-1994    bullet57@naver.com   
Principal Investigator: Sangmin M. Lee, M.D.,Ph.D.         
Sub-Investigator: Won Ho Kim, M.D.         
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

No publications provided

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01609517     History of Changes
Other Study ID Numbers: 2012-04-089-001
Study First Received: May 29, 2012
Last Updated: July 20, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Spinal anesthesia
determinant
duration

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

ClinicalTrials.gov processed this record on September 18, 2014