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Usefulness of the Tsui Test in Combined Spinal-Epidural Analgesia in Labour
This study is ongoing, but not recruiting participants.
Study NCT00464841   Information provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
First Received: April 23, 2007   Last Updated: December 12, 2007   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 23, 2007
December 12, 2007
February 2007
change in current intensity required to produce a positive Tsui test after an intrathecal injection of bupivacaine [ Time Frame: Within 2 hours of catheter placement ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00464841 on ClinicalTrials.gov Archive Site
 
 
 
Usefulness of the Tsui Test in Combined Spinal-Epidural Analgesia in Labour
Can the Tsui Test be Used to Test the Placement of Epidural Catheters Following the Intrathecal Component of a Combined Spinal-Epidural Technique Used for Labor Analgesia?

Combined spinal epidural anesthesia (CSE) is a very effective technique to provide labor analgesia. One of the disadvantages of this technique is the delay in recognizing an error in the position of the epidural catheter because of the effects of the spinal component. Eventually in case of a misplaced catheter, the patient will experience pain or discomfort requiring a repeat procedure after the effect of drug given during the spinal wears off. Low current electrical stimulation test, or the Tsui test, has been used successfully to confirm catheter location in the epidural space. The investigators' objective in this study is to test the usefulness of the Tsui test to confirm the correct placement of the epidural catheter during CSE in laboring patients.

CSE is a widely used technique to provide analgesia in laboring patients. One of the disadvantages of the CSE is the delay in recognizing the mal-position of the epidural catheter, which is initially masked due to the effects of the spinal component. A mal-positioned epidural catheter can cause unnecessary maternal discomfort and dissatisfaction, as it requires a repeat procedure when the effect of spinal drug wears off. Additionally, in the event of emergency caesarean delivery, it would be advantageous to know that the catheter is properly placed. Low current electrical stimulation test, or the Tsui test, has been used successfully to confirm catheter location in the epidural space. Our objective in this study is to test the usefulness of the Tsui test to confirm the correct placement of the epidural catheter during CSE in laboring patients.

Two groups of patients will be studied. In the first group, after the placement of the epidural catheter and noting the electric current required to elicit a motor response (maximum current used is 20 mA), a spinal needle is introduced one inter vertebral space below the space where the epidural catheter is inserted and 0.7 ml of 0.25% isobaric bupivacaine and 15 mcg of fentanyl is injected intrathecally. The epidural catheter is then re-stimulated and the magnitude of the current required to reproduce the motor response is noted. The stimulation is repeated after 5, 10, and 15 minutes. The second group consists of patients with accidental dural puncture. An intrathecal catheter is inserted and the Tsui test performed (maximum current used is 2 mA), followed by the injection of same mixture of local anesthetic and opioid as used in the first group. The Tsui test is repeated at 5, 10 and 15 minute intervals, similar to what is done in the epidural group. After 15 minutes, patients in both groups are managed as per departmental policy. In both the groups, the Tsui test will be repeated after 120 minutes during the maintenance of labor analgesia to determine the change in intensity of current required to elicit the motor response.

 
Interventional
Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Labor Pain
  • Procedure: Combined spinal epidural
  • Procedure: Tsui Test for intrathecal catheter
  • Experimental: Tsui test for combined spinal-epidural
  • Experimental: Tsui test for intrathecal catheter
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
December 2008
 

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) 1 or 2
  • Full term pregnancy
  • Patients requesting epidural in early labor

Exclusion Criteria:

  • Any contraindication to regional anesthesia
  • Allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl
  • Received prior sedatives or opioids
  • Abnormal vertebral anatomy
  • Neurological disorders with lumbar involvement
  • Patients with implanted electronic devices
Female
18 Years and older
Yes
 
Canada
 
 
NCT00464841
Dr. Jose Carvalho, Mount Sinai Hospital
06-0205-A
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 
Principal Investigator: Jose CA Carvalho, MD, PhD MOUNT SINAI HOSPITAL
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
December 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.