Pulsatile Pressure Waveform to Confirm Correct Placement of the Epidural in Laboring Patients

Analgesia, Epidural Clinical Trial

Official title:

Efficacy of the Presence of a Pulsatile Pressure Waveform to Confirm Correct Placement of the Epidural Needle and Catheter in Laboring Pregnant Patients: a Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02395796
• Other study ID #: 106323
• Status: Terminated
• Phase: N/A
• First received: March 10, 2015
• Last updated: February 24, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Epidural analgesia is highly effective for labor pain relief and is widely chosen by pregnant patients. However, placement of the epidural needle can be challenging in pregnant patients due to lax tissue ligaments and edema so that the traditional loss of resistance method (LOR) used to find the space may be subtle leading to retries which may delay onset of analgesia as well as increase the risk of complications. The ability to transduce a pulsatile pressure waveform from epidural needles placed in non-laboring patients correlates highly with successful placement of the epidural needle. We wish to evaluate the efficacy of obtaining a pulsatile pressure waveform with correct epidural needle placement in laboring women.

Description:

Patients requesting epidural labor analgesia will be eligible for recruitment. After written informed consent is obtained, placement of monitors and aseptic technique, the 17G epidural needle will be placed using the loss of resistance (LOR) technique to air or saline at the lumbar level chosen by the anesthesiologist. When LOR occurs, the needle will then be filled with 2 mL NaCl 0.9% from that syringe and the pressure monitoring accessory will be connected to the needle. The second investigator will then connect the high pressure tubing to the acessory without touching it, and the pressure will be zeroed at level of the needle insertion. Pressure will then be transduced and the waveform, recorded. An epidural catheter (SIMS Portex) will then be passed through the needle and advanced 5 cm beyond the tip of the epidural needle. After securing the epidural catheter in place, the patient will be placed on the lateral position. The catheter will then be filled NaCl 0.9% from a syringe and a high-pressure tubing extension leveled at the spine level will be connected to the catheter and the pressure will be transduced and recorded. Data recorded will include 2 parameters: 1) The presence or absence of a pulsatile waveform, and 2) The actual pressure read at the epidural space, in mmHg. Those readings will be obtained in 2 distinct moments: at a " rest" state, meaning during an interval between contractions, and at an "active" state, during the first contraction after the epidural catheter is placed. A test dose of 3 mL of 2% lidocaine with epinephrine1:200.000 will then be given to exclude potential spinal or intravascular injection. After 3 minutes, a loading dose of 10mL of 0,125% bupivacaine will be given for labor analgesia and the presence or absence of a bilateral sensorial block at T10 or higher at 30 min will be assessed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female Patients

• ASA I-III

• Term Pregnancy (>37 weeks)

• 18 years or older

• Early Labour (<6 cm of cervical dilation)

• BMI<40

Exclusion Criteria:

• Any contraindication to epidural analgesia placement (coagulopathy, sepsis, infection at site, increased ICP, hypovolemia, unstable ischemic heart disease, unstable neurologic disease, severe aortic stenosis, prior spinal surgery, LA allergy)

• Serious concern for maternal or fetal wellfare.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Analgesia, Epidural

Intervention

Procedure:
• Epidural Pressure Waveform
When loss of resistance occurs, a high-pressure tubing extension will be connected to the needle and the pressure will be transduced and the waveform, recorded. An epidural catheter will then be passed through the needle and connected to a high-pressure tubing extension and the pressure will be transduced and recorded. A test dose of 3 mL of 2% lidocaine with epinephrine 1:200.000 will then be given to exclude potential spinal or intravascular injection. After 3 minutes, a loading dose of 10 mL of 0,125% bupivacaine will be given for labor analgesia and the presence or absence of a bilateral sensorial block at T10 or higher at 30 min will be assessed.

Locations

Country	Name	City	State
Canada	Victoria Hospital- LHSC	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (7)

de Medicis E, Tetrault JP, Martin R, Robichaud R, Laroche L. A prospective comparative study of two indirect methods for confirming the localization of an epidural catheter for postoperative analgesia. Anesth Analg. 2005 Dec;101(6):1830-3. — View Citation

Ghia Jn, Arora Sk, Castillo M, Mukherji Sk. Confirmation of location of epidural catheters by epidural pressure waveform and computed tomography cathetergram. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):337-41. — View Citation

Gong Y, Shi H, Wu J, Labu D, Sun J, Zhong H, Li L, Xin X, Wang L, Wu L, Ma D. Pressure waveform-guided epidural catheter placement in comparison to the loss-of-resistance conventional method. J Clin Anesth. 2014 Aug;26(5):395-401. doi: 10.1016/j.jclinane.2014.01.015. Epub 2014 Aug 27. — View Citation

Lennox PH, Umedaly HS, Grant RP, White SA, Fitzmaurice BG, Evans KG. A pulsatile pressure waveform is a sensitive marker for confirming the location of the thoracic epidural space. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):659-63. Epub 2006 May 30. — View Citation

Messih MN. Epidural space pressures during pregnancy. Anaesthesia. 1981 Aug;36(8):775-82. — View Citation

Narang VP, Linter SP. Failure of extradural blockade in obstetrics. A new hypothesis. Br J Anaesth. 1988 Mar;60(4):402-4. — View Citation

Sivakumaran C, Ramanathan S, Chalon J, Turndorf H. Uterine contractions and the spread of local anesthetics in the epidural space. Anesth Analg. 1982 Feb;61(2):127-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural Needle Insertion Success	Presence of a pulsatile pressure waveform at the epidural needle as a good predictor of a successful epidural block 30 min after local anesthetic injection	30 min after loading dose	No
Secondary	Epidural Pressure in mmHg	Epidural pressures during uterine contractions and in-between contractions in mmHg	5 min after epidural needle insertion	No
Secondary	Epidural Waveform at the Catheter	Presence or absence of an epidural waveform measured through the epidural catheter right after insertion	Immediately after epidural catheter insertion	No