Analgesia, Obstetrical Clinical Trial
Official title:
Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
NCT number | NCT03574441 |
Other study ID # | 1048027 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 4, 2017 |
Est. completion date | March 18, 2018 |
Verified date | July 2019 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Augusta University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02557087 -
Hyoscine ButylBromide for Intrapartum Analgesia
|
Phase 2 | |
Not yet recruiting |
NCT02578251 -
Paracetamol for Intrapartum Analgesia
|
Phase 2 | |
Recruiting |
NCT06236126 -
SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain.
|
N/A | |
Completed |
NCT02509312 -
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02789410 -
Spinal Morphine vs. Hydromorphone for Pain Control After Cesarean Delivery
|
N/A | |
Completed |
NCT05099055 -
Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study
|
Phase 3 | |
Active, not recruiting |
NCT03167905 -
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
|
Phase 2/Phase 3 | |
Completed |
NCT02009722 -
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
|
Phase 4 | |
Active, not recruiting |
NCT03805607 -
IV Ketorolac on Platelet Function Post-Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02920489 -
Individualized Timing of Analgesia and Effectiveness of Labor Analgesia
|
N/A | |
Completed |
NCT02823418 -
Neuraxial Labor Analgesia and the Incidence of Postpartum Depression
|
||
Not yet recruiting |
NCT05977361 -
Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
|
N/A |