Intrapartum Epidural Catheter Displacement: Dressing Methods

Analgesia, Obstetrical Clinical Trial

Official title:

Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574441
• Other study ID #: 1048027
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: March 18, 2018

Study information

• Verified date: July 2019
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 18, 2018
• Est. primary completion date: March 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia, Obstetrical

Intervention

Device:
• 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
• Tegaderm dressing + Steri-strip dressing
Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
• Tegaderm dressing only
Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural Catheter Migration	Percentage of participants for whom catheter migration was observed	24 hours. The time from insertion to removal of catheter
Secondary	Rate of Epidural Catheter Replacement	Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm	24 hours. The time from insertion to removal of catheter due to failure