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

NCT ID: NCT02395796

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-02-29

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.

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.

Conditions

Analgesia, Epidural

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Epidural Pressure Waveform

Study Population:

• Term pregnancy
• in labour
• 18 years of age or older.

Group Type: EXPERIMENTAL

Epidural Pressure Waveform

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Ilana Sebbag

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Indu Singh, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Victoria Hospital- LHSC

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 3355735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11464353 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17023284 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25172504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16301268 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 7294338 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7198872 (View on PubMed)

Other Identifiers

106323

Identifier Type: -

Identifier Source: org_study_id