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Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 cm Versus 5 cm

Primary Purpose

Labor Pain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Epidural catheter
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring epidural catheter, epidural analgesia, labor epidural

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All women aged 18 years and above.
  • In established second stage of labor.
  • 3-7 cm dilation at time of insertion.
  • Women with BMI < 40 kg/m2

Exclusion Criteria:

  • Known contraindication to epidural insertion.
  • Inability or unwillingness to provide written consent.
  • Previous difficult epidural insertion.
  • Previous failed epidural.
  • Imminent instrumental or operative delivery.
  • Dural puncture.
  • Combined spinal epidural analgesia.
  • High BMI > 40 kg/m2

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

4 cm epidural catheter

5 cm epidural catheter

Arm Description

The epidural catheter will be thread into the epidural space at a length of 4 cm.

The epidural catheter will be thread into the epidural space at a length of 5 cm.

Outcomes

Primary Outcome Measures

Sensory block level < T10
Sensory block level to ice will be measured 1 hour after the loading dose is administered. Yes: inadequate block No: adequate block
Block height discrepancy
Unilateral block or block height discrepancy of >3 dermatomal levels at any time prior to delivery. Yes: inadequate block No: adequate block
Re-siting of the epidural
Re-siting of the epidural at any time during labour will indicate an inadequate block, for any of the following reasons: Inadequate analgesia Persistent unilateral block Persistent intravascular placement Extensive motor block Hypotension High block
Adjustment of catheter length
Adjustment of catheter length at any time during labour would also indicate an inadequate block.
Abandonment of epidural or substitute for alternative method of analgesia after initial failure: questionnaire
The epidural analgesia will also be considered inadequate if the procedure is abandoned or another method of analgesia is used. This will be recorded by the anesthesiologist.

Secondary Outcome Measures

Pain score >3 at any time during labour: questionnaire
A verbal numerical rating score (VNRS) greater than 3, where 0=no pain and 10=worst pain ever.
Number of epidural top-ups administered by the nursing team
The number of times the labour and delivery nurse has to administer a top-up of the epidural.
Number of epidural top-ups administered by the anesthesiologist
The number of times the anesthesiologist has to administer a top-up of the epidural.
Pain scores recorded throughout labour: questionnaire
A verbal numerical rating score (VNRS), where 0=no pain and 10=worst pain ever. A verbal numerical rating score (VNRS) greater than 3, where 0=no pain and 10=worst pain ever.
Hourly sensory block height assessment
Hourly sensory block height assessment, using sensation to ice. This is recorded hourly as standard practice.
Incidence of intravascular epidural placement
Any incidence of intravascular epidural placement during labour will be recorded.
Incidence of catheter dislodgement
Any incidence of catheter dislodgement during labour will be recorded.
Motor block using Bromage scale
Bromage scale will be recorded hourly as standard practice. 3: Unable to move feet or knees 2: Able to move feet only 1: Able to just move knees 0: Full flexion of knees and feet
Presence of paresthesia on insertion.
Any presence of paresthesia on insertion will be recorded.
Adequacy of conversion to surgical block if required for cesarean delivery: questionnaire
Adequacy of conversion to surgical block in cases requiring cesarean deliveries for failed labor or fetal issues. This will be recorded by the anesthesiologist.

Full Information

First Posted
June 25, 2021
Last Updated
January 12, 2023
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04946032
Brief Title
Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 cm Versus 5 cm
Official Title
Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 cm Versus 5 cm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Epidural analgesia was introduced to the world of obstetrics in 1909 by Walter Stoeckel. Over the following 100 years it has developed to become the gold-standard for delivery of intra-partum analgesia, with between 60 and 75% of North American parturients receiving an epidural during their labor. Effective labor analgesia has been shown to improve maternal and fetal outcomes. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space. Dislodgement or displacement of epidural catheter remains a significant cause for failure with analgesia. Novel methods of fixation may further reduce the risk of catheter migration. Another factor is the direction of travel within the epidural space, only 13% of lumbar catheters remain uncoiled after insertion of more than 4 cm into the epidural space. Hypothesis: The investigators hypothesize that catheters inserted to 4 cm will have a lower rate of failure when compared to those inserted to 5 cm. Objective: This study aims to evaluate the difference in quality of labor analgesia delivered by epidural catheters inserted to either 4 or 5 cm into the epidural space. This study will be conducted as an interventional double-blinded randomised control trial to establish best practice.
Detailed Description
Effective labor analgesia has been shown to improve maternal and fetal outcomes. It is of paramount importance to the obstetric anesthesiologist to optimize the quality of labor analgesia and identify any factors leading to ineffective epidural analgesia. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space. Previous studies have advocated, for varying reasons, different lengths of catheter to be left in the space; these range from 2cm to 8cm. Longer epidural lengths in the space can be associated with foraminal escape, leading to unilateral block, and intravascular insertion, prompting additional manipulation. Shorter lengths have previously been associated with more frequent dislodgement. The directionality of the epidural catheter once in the space has been demonstrated to correlate with misdirection. The aim of the study would be to standardize practice in how much epidural catheter is threaded into the epidural space.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
epidural catheter, epidural analgesia, labor epidural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The anesthesiologist placing the epidural will know the group assignment.
Allocation
Randomized
Enrollment
398 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 cm epidural catheter
Arm Type
Active Comparator
Arm Description
The epidural catheter will be thread into the epidural space at a length of 4 cm.
Arm Title
5 cm epidural catheter
Arm Type
Active Comparator
Arm Description
The epidural catheter will be thread into the epidural space at a length of 5 cm.
Intervention Type
Other
Intervention Name(s)
Epidural catheter
Other Intervention Name(s)
epidural
Intervention Description
The epidural catheter length will vary, either 4 cm or 5 cm into the epidural space.
Primary Outcome Measure Information:
Title
Sensory block level < T10
Description
Sensory block level to ice will be measured 1 hour after the loading dose is administered. Yes: inadequate block No: adequate block
Time Frame
1 hour
Title
Block height discrepancy
Description
Unilateral block or block height discrepancy of >3 dermatomal levels at any time prior to delivery. Yes: inadequate block No: adequate block
Time Frame
24 hours
Title
Re-siting of the epidural
Description
Re-siting of the epidural at any time during labour will indicate an inadequate block, for any of the following reasons: Inadequate analgesia Persistent unilateral block Persistent intravascular placement Extensive motor block Hypotension High block
Time Frame
24 hours
Title
Adjustment of catheter length
Description
Adjustment of catheter length at any time during labour would also indicate an inadequate block.
Time Frame
24 hours
Title
Abandonment of epidural or substitute for alternative method of analgesia after initial failure: questionnaire
Description
The epidural analgesia will also be considered inadequate if the procedure is abandoned or another method of analgesia is used. This will be recorded by the anesthesiologist.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score >3 at any time during labour: questionnaire
Description
A verbal numerical rating score (VNRS) greater than 3, where 0=no pain and 10=worst pain ever.
Time Frame
24 hours
Title
Number of epidural top-ups administered by the nursing team
Description
The number of times the labour and delivery nurse has to administer a top-up of the epidural.
Time Frame
24 hours
Title
Number of epidural top-ups administered by the anesthesiologist
Description
The number of times the anesthesiologist has to administer a top-up of the epidural.
Time Frame
24 hours
Title
Pain scores recorded throughout labour: questionnaire
Description
A verbal numerical rating score (VNRS), where 0=no pain and 10=worst pain ever. A verbal numerical rating score (VNRS) greater than 3, where 0=no pain and 10=worst pain ever.
Time Frame
24 hours
Title
Hourly sensory block height assessment
Description
Hourly sensory block height assessment, using sensation to ice. This is recorded hourly as standard practice.
Time Frame
24 hours
Title
Incidence of intravascular epidural placement
Description
Any incidence of intravascular epidural placement during labour will be recorded.
Time Frame
24 hours
Title
Incidence of catheter dislodgement
Description
Any incidence of catheter dislodgement during labour will be recorded.
Time Frame
24 hours
Title
Motor block using Bromage scale
Description
Bromage scale will be recorded hourly as standard practice. 3: Unable to move feet or knees 2: Able to move feet only 1: Able to just move knees 0: Full flexion of knees and feet
Time Frame
24 hours
Title
Presence of paresthesia on insertion.
Description
Any presence of paresthesia on insertion will be recorded.
Time Frame
1 hour
Title
Adequacy of conversion to surgical block if required for cesarean delivery: questionnaire
Description
Adequacy of conversion to surgical block in cases requiring cesarean deliveries for failed labor or fetal issues. This will be recorded by the anesthesiologist.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All women aged 18 years and above. In established second stage of labor. 3-7 cm dilation at time of insertion. Women with BMI < 40 kg/m2 Exclusion Criteria: Known contraindication to epidural insertion. Inability or unwillingness to provide written consent. Previous difficult epidural insertion. Previous failed epidural. Imminent instrumental or operative delivery. Dural puncture. Combined spinal epidural analgesia. High BMI > 40 kg/m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mrinalini Balki, MD
Phone
416-586-4800
Ext
5270
Email
mrinalini.balki@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Phone
416-586-4800
Ext
5270
Email
mrinalini.balki@uhn.ca
First Name & Middle Initial & Last Name & Degree
William Turner, MD
First Name & Middle Initial & Last Name & Degree
Linda Boonstra-Verbraak, MD
First Name & Middle Initial & Last Name & Degree
Kristi Downey, MSc
First Name & Middle Initial & Last Name & Degree
Naveed Siddiqui, MD

12. IPD Sharing Statement

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Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 cm Versus 5 cm

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