Intrapartum Epidural Catheter Displacement: Dressing Methods

• ClinicalTrials.gov Identifier: NCT03574441
• Recruitment Status: Completed
• First Posted: July 2, 2018
• Results First Posted: July 30, 2019
• Last Update Posted: July 30, 2019
• Sponsor: Augusta University
• Information provided by (Responsible Party): Efrain Riveros Perez, MD, Augusta University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Analgesia, Obstetrical	Device: Tegaderm dressing + catheter support pad; Device: Tegaderm dressing + Steri-strip dressing; Device: Tegaderm dressing only	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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

• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
• Actual Study Start Date: December 4, 2017
• Actual Primary Completion Date: March 11, 2018
• Actual Study Completion Date: March 18, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: TegadermTM only	Device: Tegaderm dressing only; Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
Active Comparator: Dressing with TegadermTM plus Steri-StripTM bands	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
Experimental: Dressing with TegadermTM plus catheter support pad.	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

Outcome Measures

Primary Outcome Measures :

1. Epidural Catheter Migration [ Time Frame: 24 hours. The time from insertion to removal of catheter ]
   Percentage of participants for whom catheter migration was observed

Secondary Outcome Measures :

1. Rate of Epidural Catheter Replacement [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Georgia

Augusta University

Augusta, Georgia, United States, 30912

Sponsors and Collaborators

Augusta University

  Study Documents (Full-Text)

Documents provided by Efrain Riveros Perez, MD, Augusta University:

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2017

More Information

• Responsible Party: Efrain Riveros Perez, MD, Assistant Professor Department of Anesthesiology and Perioperative Medicine, Augusta University
• ClinicalTrials.gov Identifier: NCT03574441
• Other Study ID Numbers: 1048027
• First Posted: July 2, 2018
• Results First Posted: July 30, 2019
• Last Update Posted: July 30, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No