NCT03574441

Intrapartum Epidural Catheter Displacement: Dressing Methods

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Analgesia, Obstetrical

Interventions

Type	Name	Description
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
DEVICE	Tegaderm dressing + Steri-strip dressing	Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
DEVICE	Tegaderm dressing only	Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter

Timeline

• Start date: 2017-12-04
• Primary completion: 2018-03-11
• Completion: 2018-03-18
• First posted: 2018-07-02
• Last updated: 2019-07-30
• Results posted: 2019-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study