Intrapartum Epidural Catheter Displacement: Dressing Methods

Not Applicable

Completed

• Conditions: Analgesia, Obstetrical
• Interventions: Device: Tegaderm dressing only; Device: Tegaderm dressing + Steri-strip dressing; Device: Tegaderm dressing + catheter support pad

• Registration Number: NCT03574441
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study Start: 2017-12-04
• Primary Completion: 2018-03-11
• Study Completion: 2018-03-18
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-02
• Results First Submitted: 2019-06-17
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Results First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TegadermTM only	Tegaderm dressing only	-
Dressing with TegadermTM plus Steri-StripTM bands	Tegaderm dressing + Steri-strip dressing	-
Dressing with TegadermTM plus catheter support pad.	Tegaderm dressing + catheter support pad	-

Primary Outcome Measures

Name	Time	Method
Epidural Catheter Migration	24 hours. The time from insertion to removal of catheter	Percentage of participants for whom catheter migration was observed

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States