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NCT Number: NCT01609517

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

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.

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Key information

Conditions

Spinal Anesthesia Success or Failure of Spinal Anesthesia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia (heavy bupivacaine)

Drug

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

Other names: Spinal anesthesia, heavy bupivacaine

Primary outcomes

  1. spinal anesthetic success/ failure

    Time frame: 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 outcomes

  1. Peak level of sensory block at anesthesia induction

    Time frame: during 20 min after anesthetic induction

    Sensory block levels determined by pinprick test

  2. Spinal anesthesia sensory/motor block level at the end of surgery

    Time frame: 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.

  3. the incidence of tourniquet pain

    Time frame: at 90 min afer anesthetic induction

    the incidence of tourniquet pain during the tourniquet time reported by the patient (NRS >= 2)

  4. Incidence of hypotension, bradycardia

    Time frame: during 2 hours after anesthesia induction

    Incidence of hypotension, bradycardia total dose of ephedrine Lowest mean blood pressure Incidence of vomiting, shivering

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 1, 2012
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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