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

Completed

• Conditions: Success or Failure of Spinal Anesthesia; Spinal Anesthesia
• Interventions: Drug: Spinal anesthesia (heavy bupivacaine)

• Registration Number: NCT01609517
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

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

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Exclusion Criteria

• Bupivacaine allergy
• medical history of spinal surgery
• Diabetic neuropathy
• active infection at the lumbosacral area
• other contraindication of spinal anesthesia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese group	Spinal anesthesia (heavy bupivacaine)	patients with BMI \>= 30.0 kg/m2 who received spinal anesthesia with heavy marcaine
Non-obese group	Spinal anesthesia (heavy bupivacaine)	patients with BMI \< 30.0 kg/m2 who received spinal anesthesia with heavy marcaine

Primary Outcome Measures

Name	Time	Method
spinal anesthetic success/ failure	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

Name	Time	Method
Incidence of hypotension, bradycardia	during 2 hours after anesthesia induction	Incidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering
Spinal anesthesia sensory/motor block level at the end of surgery	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	at 90 min afer anesthetic induction	the incidence of tourniquet pain during the tourniquet time reported by the patient (NRS \>= 2)
Peak level of sensory block at anesthesia induction	during 20 min after anesthetic induction	Sensory block levels determined by pinprick test

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of