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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609517
• Other study ID #: 2012-04-089-001
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: October 29, 2014
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Anesthesia
• Success or Failure of Spinal Anesthesia

Intervention

Drug:
• Spinal anesthesia (heavy bupivacaine)
Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spinal anesthetic success/ failure	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.	at 2 hour after the anesthetic induction	No
Secondary	Peak level of sensory block at anesthesia induction	Sensory block levels determined by pinprick test	during 20 min after anesthetic induction	No
Secondary	Spinal anesthesia sensory/motor block level 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.	2 hours after induction (at the end of surgery)	No
Secondary	the incidence of tourniquet pain	the incidence of tourniquet pain during the tourniquet time reported by the patient (NRS >= 2)	at 90 min afer anesthetic induction	No
Secondary	Incidence of hypotension, bradycardia	Incidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering	during 2 hours after anesthesia induction	No