- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02395796
Pulsatile Pressure Waveform to Confirm Correct Placement of the Epidural in Laboring Patients
February 24, 2016 updated by: Ilana Sebbag, Lawson Health Research Institute
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5A5
- Victoria Hospital- LHSC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epidural Pressure Waveform
Study Population:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epidural Needle Insertion Success
Time Frame: 30 min after loading dose
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epidural Pressure in mmHg
Time Frame: 5 min after epidural needle insertion
|
Epidural pressures during uterine contractions and in-between contractions in mmHg
|
5 min after epidural needle insertion
|
Epidural Waveform at the Catheter
Time Frame: Immediately after epidural catheter insertion
|
Presence or absence of an epidural waveform measured through the epidural catheter right after insertion
|
Immediately after epidural catheter insertion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Indu Singh, MD, FRCPC, University of Western Ontario, Schulich School of Medicine, Department of Anesthesia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Messih MN. Epidural space pressures during pregnancy. Anaesthesia. 1981 Aug;36(8):775-82. doi: 10.1111/j.1365-2044.1981.tb08815.x.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 24, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 106323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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