Analgesia, Obstetrical
Conditions
Brief summary
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. Epidural migration has been documented in both the obstetric and non-obstetric settings. 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. Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.
Detailed description
Primary aim: The investigators 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 catheter support pad dressing is superior to the dressing with TegadermTM plus Steri-StripTM bands, 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.
Interventions
DEVICETegaderm dressing + Steri-strip dressing
Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
DEVICETegaderm dressing + catheter support pad
Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
DEVICETegaderm dressing only
Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients were 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 catheter support pad. 2. Dressing with TegadermTM plus Steri-StripTM bands 3. Dressing with TegadermTM only
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epidural Catheter Migration | 24 hours. The time from insertion to removal of catheter | Percentage of participants for whom catheter migration was observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Epidural Catheter Replacement | 24 hours. The time from insertion to removal of catheter due to failure | Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TegadermTM Only Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter | 31 |
| Dressing With TegadermTM Plus Steri-StripTM Bands Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter | 30 |
| Dressing With TegadermTM Plus Catheter Support Pad. Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter | 30 |
| Total | 91 |
Baseline characteristics
| Characteristic | TegadermTM Only | Dressing With TegadermTM Plus Steri-StripTM Bands | Dressing With TegadermTM Plus Catheter Support Pad. | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 30 Participants | 30 Participants | 91 Participants |
| Age, Continuous | 25 years | 24 years | 25 years | 24 years |
| Gestational age | 36 Weeks | 37 Weeks | 37 Weeks | 36 Weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 19 Participants | 20 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 10 Participants | 30 Participants |
| Region of Enrollment United States | 31 participants | 30 participants | 30 participants | 91 participants |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 30 Participants | 91 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Epidural Catheter Migration
Percentage of participants for whom catheter migration was observed
Time frame: 24 hours. The time from insertion to removal of catheter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TegadermTM Only | Epidural Catheter Migration | 44 percentage patients catheter migration |
| Dressing With TegadermTM Plus Steri-StripTM Bands | Epidural Catheter Migration | 25 percentage patients catheter migration |
| Dressing With TegadermTM Plus Catheter Support Pad. | Epidural Catheter Migration | 17 percentage patients catheter migration |
Secondary
Rate of Epidural Catheter Replacement
Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm
Time frame: 24 hours. The time from insertion to removal of catheter due to failure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TegadermTM Only | Rate of Epidural Catheter Replacement | 3.2 percentage of catheters |
| Dressing With TegadermTM Plus Steri-StripTM Bands | Rate of Epidural Catheter Replacement | 3.3 percentage of catheters |
| Dressing With TegadermTM Plus Catheter Support Pad. | Rate of Epidural Catheter Replacement | 3.3 percentage of catheters |