The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
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Purpose
In these prospective observational study, the investigators are trying to evaluate (1) the influence of body-mass index on spinal anesthetic outcome by survival analysis and (2) the relative influence of these determinants on spinal anesthetic outcome by logistic regression analysis.
| Condition | Intervention |
|---|---|
|
Spinal Anesthesia Success or Failure of Spinal Anesthesia |
Drug: Spinal anesthesia (bupivacaine with or without fentanyl, epinephrine) |
| 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 |
- spinal anesthetic success/ failure [ Time Frame: at 2 hour after the anesthetic induction (at the time of patient's report of pain) ] [ Designated as safety issue: No ]spinal anesthetic success/ failure as determined by the patient's self-report of pain (NRS >= 2) before the end of surgery
- Time to patient's first report of pain [ Time Frame: at 3 hour after anesthetic induction (at the time of patient's report of pain) ] [ Designated as safety issue: No ]Time to patient's first report of pain from successful anesthetic induction
- Spinal anesthesia block level [ Time Frame: 2, 5, 10, 15 min after anesthetic induction, at the surgery end ] [ 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)
| Estimated Enrollment: | 175 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Obese group
patients with BMI >= 27.5 kg/m2
|
Drug: Spinal anesthesia (bupivacaine with or without fentanyl, epinephrine)
Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg with or without fentanyl 20 mcg, epinephrine 100 mcg, 200 mcg
Other Names:
|
|
Non-obese group
patients with BMI < 27.5 kg/m2
|
Drug: Spinal anesthesia (bupivacaine with or without fentanyl, epinephrine)
Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg with or without fentanyl 20 mcg, epinephrine 100 mcg, 200 mcg
Other Names:
|
Detailed Description:
Though the spread of spinal anesthetic drug is unpredictable, patients factors (age, gender, height,weight, body-mass index), spinal anatomy, anesthetic drug, additive (epinephrine, opioid) 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 by survival analysis 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 |
Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
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| 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 |
| 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. | |
| 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: | May 31, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
Spinal anesthesia determinant duration |
Additional relevant MeSH terms:
|
Anesthetics Anesthetics, Local Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Epinephrine Epinephryl borate Bupivacaine Fentanyl Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Central Nervous System Depressants Central Nervous System Agents Sensory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013