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

NCT02395796 | Terminated

• 1 other identifier: 106323
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia, Epidural

Keywords

epidural; labor analgesia; pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Epidural Pressure in mmHg

  5 min after epidural needle insertion

• Epidural Waveform at the Catheter

  Immediately after epidural catheter insertion

Study Arms (1)

Epidural Pressure Waveform

EXPERIMENTAL

Study Population: * Term pregnancy * in labour * 18 years of age or older.

Procedure: Epidural Pressure Waveform

Interventions

Epidural Pressure Waveform PROCEDURE

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.

Epidural Pressure Waveform

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Patients
• ASA I-III
• Term Pregnancy (\>37 weeks)
• years or older
• Early Labour (\<6 cm of cervical dilation)
• BMI\<40

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Victoria Hospital- LHSC

London, Ontario, N6A 5A5, Canada

Location

Related Publications (7)

• Narang VP, Linter SP. Failure of extradural blockade in obstetrics. A new hypothesis. Br J Anaesth. 1988 Mar;60(4):402-4. doi: 10.1093/bja/60.4.402.

  PMID: 3355735 BACKGROUND

• 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. doi: 10.1053/rapm.2001.23932.

  PMID: 11464353 BACKGROUND

• 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. doi: 10.1053/j.jvca.2006.02.022. Epub 2006 May 30.

  PMID: 17023284 BACKGROUND

• 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.

  PMID: 25172504 BACKGROUND

• 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):1830-1833. doi: 10.1213/01.ANE.0000184130.73634.BE.

  PMID: 16301268 BACKGROUND

• Messih MN. Epidural space pressures during pregnancy. Anaesthesia. 1981 Aug;36(8):775-82. doi: 10.1111/j.1365-2044.1981.tb08815.x.

  PMID: 7294338 BACKGROUND

• 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.

  PMID: 7198872 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Indu Singh, MD, FRCPC

  University of Western Ontario, Schulich School of Medicine, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 24, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 25, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)