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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01609517
Enrollment
209
Registered
2012-06-01
Start date
2012-05-31
Completion date
2012-12-31
Last updated
2014-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Success or Failure of Spinal Anesthesia

Keywords

Spinal anesthesia, determinant, duration

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.

Interventions

Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
spinal anesthetic success/ failureat 2 hour after the anesthetic inductionwhen (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

MeasureTime frameDescription
Peak level of sensory block at anesthesia inductionduring 20 min after anesthetic inductionSensory block levels determined by pinprick test
Spinal anesthesia sensory/motor block level at the end of surgery2 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 painat 90 min afer anesthetic inductionthe incidence of tourniquet pain during the tourniquet time reported by the patient (NRS \>= 2)
Incidence of hypotension, bradycardiaduring 2 hours after anesthesia inductionIncidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026