Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
Phase: NA
Conditions: Analgesia, Obstetrical
Sponsor: Augusta University

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COVER PAGE 
 
Official Title of the Study 
Intrapartum epidural catheter displacement: Comparison of three dressing methods in 
morbidly obese parturients   
 
NCT Number  
NCT03574441 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol Title: Intrapartum epidural catheter displacement: Comparison of three 
dressing methods in morbidly obese parturients   
Principal Investigator: Efrain Riveros Perez MD 
1. Objectives 
Purpose, specific aims, and hypothesis: 
Purpose: We propose this study to prospectively evaluate the efficacy of the three types of epidural 
catheter dressings that we currently use in our Labor and Delivery unit, in terms of catheter 
migration, taking into consideration the influence of body mass index on this variable.                                     
Primary aim: We will evaluate the efficacy of three different epidural catheter dressing systems in 
laboring patients.                                                                                                                       
Secondary aims: To compare the effect of different degrees of obesity measured by BMI, on 
epidural catheter migration and quality and failure of epidural labor analgesia. To evaluate the 
effect of time an indwelling catheter remains in place, level of insertion and patient’s height on 
epidural catheter migration.                                                                                                                   
Hypothesis: The use of dressing with transparent TegadermTM plus SorbaView SHIELD® dressing 
is superior to the dressing with TegadermTM plus Steri-StripTM bands in addition to a catheter 
support pad, and to a dressing with TegadermTM only, for epidural catheter fixation in laboring 
obese and morbidly obese patients, in terms of catheter migration. epidural quality and failure and 
epidural catheter replacement in the labor analgesia setting.  

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2. Background 
Background and rationale for the study: 
Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of 
epidural failure was shown to be 12% in a retrospective analysis of 19.259 deliveries (1). Epidural migration 
has been documented in both the obstetric and non-obstetric settings (2,3). It has been argued that 
prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed 
epidurals in obstetrics (4,5). Motamed et al showed that 45% of epidural failures in major abdominal 
surgery could be attributable to catheter migration (6). Phillips et al studied epidural catheter migration in 
labor finding an incidence of 54% (7). Migration was 2 cm on average and tended to be directed inward. 
Crosby et al found a similar incidence of catheter migration but in an outward direction (8). 
 
Factors influencing catheter migration include weight, body mass index, depth of the epidural space and 
patient positioning (9,10). Bishton et al documented inward migration in 13% and outward displacement of 
one or more centimeters in 22% of patients in a cohort of 153 laboring patients (10). They also found that 
all cases of failed epidural occurred in patients with outward migration greater than 2,5 cm (10). Hamilton 
et al showed an association between patient position change and movement of epidural catheters, when the 
patient is sitting with a straight back and when placed on lateral decubitus position (11). The authors found 
that the magnitude of epidural catheter movement was more pronounced in patients with BMI >30 kg/m2. 
It has been hypothesized that the epidural catheter might be fixed to the ligamentum flavum after it is 
threaded, as the maximum pressure found during catheter placement corresponds to this anatomical 
structure (12). When the patient changes position after taping the catheter, especially in the case of a 
parturient with high BMI, the new anchor point theoretically moves to the skin, facilitating outward 
migration of the epidural catheter (9). 
 
Some authors have evaluated the influence of different dressing methods on epidural catheter migration. 
Burns et al compared TegadermTM dressing, TegadermTM plus filter-shoulder fixation and Niko Epi-Fix 
dressing in 113 patients in labor (2), finding that TegadermTM plus filter-shoulder was superior in terms of 
minimization of epidural catheter displacement. Their study doesn’t mention weight or BMI of patients 
included in the study. Odor et al evaluated the efficacy of Epi-FixTM, Lockit Plus® and TegadermTM for 
dressing of intrapartum catheters, finding superiority of the Lockit Plus® system to decrease catheter 
migration and epidural analgesic failure (13). The authors didn’t evaluate the effect of BMI on the outcomes 
and even excluded patients with BMI >50 kg/m2. Similar results were reported by Clark et al in a cohort of 
102 patients having epidural catheters for major non-obstetric procedures (14). 
 
The obstetric population treated at the Labor and Delivery Unit at Augusta University Medical Center is 
characterized by a high incidence of obesity and morbid obesity. This situation makes insertion and 
management of epidural labor analgesia catheters particularly challenging. Although the influence of BMI 
on catheter migration has been suggested; to our knowledge, no study to date has evaluated epidural 
catheter migration in a high BMI obstetric population. Evaluating these type of association is clinically 
relevant as epidural failure is a situation that might potentially compromise patient safety. It may increase 
the rate of epidural replacement with the concomitant technical difficulties and the potential need to use 
general anesthesia in cases of unplanned cesarean section in a patient with an indwelling epidural catheter. 
This latter situation is particularly hazardous, knowing the increased incidence of difficult airway in both 
obstetric and obese patients (15). We propose this study to compare the effect of three different epidural 
catheter dressing systems in patients with BMI >30 kg/m2 on epidural catheter migration and epidural 
quality and failure in the labor analgesia setting. 

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3. Inclusion and Exclusion Criteria 
Inclusion criteria will be the following: 
1) Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request 
epidural analgesia. 
2) BMI >30 kg/m2. 
3) Age older than 18 years old. 
Exclusion criteria are the following: 
1) Allergy to adhesive tape or to the components of the dressings used in the study. 
2) Preexisting sensory neurologic deficits affecting lower extremities. 
3) Patients taken to the operating room for cesarean section during the study period. 
4) Chronic pain conditions. 
5) Patients with intrathecal catheters. 
 
4. Number of Subjects/Records/Samples Collected 
Total number of subjects to be accrued/records reviewed/samples collected: 
Based on previous experiences for a measurable difference of 0,5 cm, we will include 35 patients in 
each group to have a power of 90% and a statistical significance level of 0,05. 
 
5. Recruitment Methods 
Recruitment methods: 
Patients who request labor epidural and fulfill inclusion criteria will be included in the study and 
randomly assigned to one of the three study groups.  
 
 
 
6. Procedures Involved 
a. Procedures involved to include those procedures that are standard evaluation and/or care 
and those that are solely for research purposes: 
After approval by the Institutional Review Board, we will obtain consent from the participant patients  
Patients will be randomized using a random number table to be allocated to one of three groups with sealed 
envelopes, based on the type of dressing to be used to secure the epidural catheter after its insertion: 
1) TegadermTM plus SorbaView SHIELD® dressing 
2) Dressing with TegadermTM plus Steri-StripTM bands in addition to a catheter support pad (All 
included in the epidural kit) 
3) dressing with TegadermTM only 
Patients will have an epidural catheter placed for labor. We will use the standard epidural kit (Smiths Medical 
ASD Inc. Keene, NH. USA). The technique will consist of the use of a 17G Tuohy needle using a midline 

Version No. 1. April 17, 2017 
 
approach with the patient in the sitting position. Localization of the epidural space will take place using loss 
of resistance to air or saline per anesthesiologist’s preference. A 20G epidural catheter will be inserted to 
leave 5 cm into the epidural space (distal to the tip of the Tuohy needle). After the Tuohy needle is removed 
and the catheter is considered to be at an adequate depth, the patients will be asked to sit up straight. Then, 
a test dose with 3 mL of Lidocaine 1,5% with epinephrine 1:200.000 will be injected through the catheter 
into the epidural space, and a dressing varying depending on the assigned group will be applied. The rest of 
the catheter will be secured longitudinally along the patient’s back over the shoulder. 
b. Study design: 
This is a randomized controlled clinical trial. 
c. Procedures performed to lessen the probability or magnitude of risks: 
The application of the three types of epidural dressings analyzed in this study are part of our current 
standard clinical practice. There is no additional risk due to our intervention. We will protect the 
rights of the patient maintaining confidentiality (records will be de-identified and assigned a study 
number) and patients can revoke their consent to participate at any moment during the study. Visual 
evaluation of the site of insertion of the epidural catheter will be inspected during the study period 
and any signs of topical or allergic reactions to any of the components used for dressing will be 
identified and treated accordingly should it happen. 
d. Duration of an individual subject’s participation in the study and the time involved: 
The patients will be participating in the study for as long as the epidural catheter remains 
in place for clinical indications. The expected time will be between 6 and 12 hours. 
 
 
7. Data and Specimen Management 
a. Data analysis plan: 
Sample size: Based on previous experiences for a measurable difference of 0,5 cm, we will 
include 35 patients in each group to have a power of 90% and a statistical significance level 
of 0,05. Data will be analyzed using analysis of variance, Student’s t test, chi-square test 
and Pearson’s correlation coefficients where appropriate. 
☐  N/A       
 
b. Power analysis: 
See above 
☐  N/A       
c. Data handling: 
☐  N/A       
i. 
Information included in the data  
Following dressing application, demographic variables of each patient will be recorded including (age, 
gravity, parity, weeks of gestation, weight, height, BMI). Other recorded variables include time of insertion, 
distance from catheter tip to skin in centimeters. One hour after delivery, immediately before catheter 
removal, time, duration of catheter presence, centimeters from skin to catheter tip and dressing integrity will 
be recorded. Dermatomal level and symmetry of the block will be recorded every two hours or every time 
the patients requires a top-up dose. We will also record number of top up doses and rate of epidural infusion 
as well as the need for catheter replacement during the observation period. 

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Primary outcomes 
Epidural catheter migration (ECM) in centimeters = Distance from tip to skin at insertion - Distance from 
tip to skin at removal. If the catheter moves inward, ECM will be negative and if it gets displaced outwardly, 
ECM will be positive. 
Secondary outcomes 
1) Dermatomal sensory level measured with thermal discrimination 
2) Incidence of asymmetric block 
3) Rate of epidural catheter replacement 
4) Total epidural dose (mL) 
5) Number of top-up epidural boluses. 
ii. 
Data storage 
Data derived from the study will be stored in a locked drawer in the office of the PI 
for the duration of the study. The de-identified information will be accessed by the 
research team and the statistician for analysis. 
iii. 
Duration of data storage 
For one year after study completion. 
iv. 
Access to data 
The PI and the research team. 
v. 
Responsible for receipt or transmission of the data  
The Principal Investigator 
vi. 
Data transport 
From the site of data collection to the PI office by the Principal Investigator. 
 
 
8. Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
a. Data safety and delivery plan 
The Principal Investigator (PI) will be responsible for the conduct of this study, including overseeing 
participant confidentiality, executing the Data and safety Monitoring (DSM) plan, and complying with all 
reporting requirements to local and federal authorities. This oversight will be accomplished through 
additional oversight from a Data and Safety Monitoring Committee at the Augusta University. We will 
conduct ongoing review of all serious adverse events (SAEs), unanticipated problems (UAPs) and 
reportable adverse events (AEs). Per the DSM Plan, SAEs, UAPs and reportable AEs will be reported to 
the institutional committee and IRB per study protocol.  All SAEs, UAPs and reportable AEs are to be 
reported to the committee and IRB within 5 business days of receiving notification of the occurrence. 

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Audits will consist of a review of the regulatory documents, consent forms, and source data verification.  
Results and recommendations from audits will then need to be submitted by the PI to the IRB of record at 
the time of the continuing review. 
b. Data review. 
We will review the results for analysis at the end of data collection. The participants will be 
informed from the beginning of the study that any concerns related to the study be 
communicated directly to the PI, who will address them according to the DSM plan. 
c. Collection of safety information 
Data will be de-identified right after collection and be kept as paper record in the PI office. 
d. Frequency of data collection 
Data will be collected daily. 
e. Responsible of data review. 
The research team (PI and 2 co-investigators) will collect and analyze data. 
f. Frequency of data review 
Every week there will be a review of the cumulative data. 
g. Conditions that trigger an immediate suspension of the research. 
N/A 
 
9. Withdrawal of Subjects                                                                     ☐ N/A       
a. Anticipated circumstances under which subjects will be withdrawn from the 
research without their consent. 
Patients will be withdrawn from the study if she develops an allergic or topical 
reaction to dressing or if the dressing has to be replaced due to soiling or bleeding. 
 
 
☐  N/A       
b. Procedures for orderly termination. 
If during the preliminary data review one of the dressings is performing 
significantly better or worse than the others, or if one of the groups has higher 
incidence of catheter migration than that reported in the literature, the study will 
be terminated and the results analyzed up to that point. 
☐  N/A       
c. Procedures that will be followed when subjects withdraw from the research 
If there is withdrawal of consent or if a subject is withdrawn without consent for 
the circumstances cited above, those cases will be included in the analysis as “lost 
to follow-up” and reported in the results section. 
☐  N/A       
 

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10. Risks to Subjects 
a. Foreseeable risks.  
No risks additional to standard clinical care are foreseen. Topical or allergic reactions to the 
dressing materials would be managed by removal of the dressing and topical treatments. 
 
b. Costs that subjects may be responsible for because of participation in the 
research. 
N/A 
☐  N/A       
c. Risks to others who are not subjects. 
N/A 
☐  N/A       
 
11.  Potential Benefits to Subjects 
There is no direct benefit to patients expected from their participation in this study. It is hoped the 
knowledge gained will be of benefit to other patients in the future. 
 
12.  Confidentiality 
Procedures for maintenance of confidentiality. 
See above 
 
 
13.  Consent Process 
Before enrollment in the study, patients will be explained the purposes of the study, the risks and 
the procedures that will take place as part of the study. Time will be given to answer questions and 
PI contact information will be provided. Then, the patient will be given the opportunity to decide 
about participation in the study by signing the consent. The possibility of revoking the consent at 
any time during the study will also be explained (See consent form for details).. 
 
14.  Compensation for Research-Related Injury                      
This section is not required when research involves no more than Minimal Risk to subjects.☒ N/A 
a. 
Describe the available compensation in the event of research related injury. 
N/A 
15.  Resources Available                                                                        ☐  N/A       
a. 
Availability of medical or psychological resources that subjects might need as a result of 
an anticipated consequences of the human research. 
N/A 

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b. 
Process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions. 
The PI and the two co-investigators will collect and analyze date and are fully aware of the 
protocol as they participated in its construction. A statistician will assist with analysis and 
he will have access to tabulated de-identified information. 
.