MedTrace Logo

Patient-Controlled Epidural Analgesia After Uterine Artery Embolization

NCT02236585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-05-23

No results posted yet for this study

Summary

Uterine artery embolization (UAE) is commonly used to treat symptomatic uterine leiomyomata through induction of infarction and subsequent hyaline degeneration. This could be followed with variable severity of pain that lasts for several days after the procedure secondary to the resulted global uterine ischemia and fibroid infarction. Pain after UAE has been described as moderate to severe cramping increasing over the first 2 hours after UAE to reach plateaus for 5 to 8 hours before it rapidly decreases to a much lower level.1 The severity of pain after UAE seems unrelated to the uterine or fibroid size which makes the severity of pain is unpredictable.1

Pain management after UAE most often consists of a combination of a non-steroidal anti-inflammatory drugs, acetaminophen and an opioid. However severe pain following embolization of the uterine arteries may require large doses of parenteral opioids for relief with added unwanted effects.2

Additionally, patients received morphine intravenous patient-controlled analgesia (IV-PCA) after UAE needed considerable amounts of morphine (median \[range\] 24 mg \[0-86 mg\]) during the first 24 h after embolization.3 The addition of ketamine to IV-PCA failed to reduce morphine consumption for the first 24 hours after UAE. 2

Nowadays, the use of lumbar epidural anesthesia has been standardized as the anesthetic choice for uterine artery embolization as it improves patients satisfaction and reduces the severity of post-procedural pain.

Although some investigators suggest an epidural analgesia for pain control after UAE,4 the use of continuous lumbar epidural infusion of ropivacaine does not improve quality of pain management after UAE.5

Thus in an observational study included few patients, the investigators demonstrated considerable postoperative analgesia lasted for 24 hours after UAE with the combined use of patient-controlled thoracic epidural analgesia (PCEA) and rectal diclofenac.6 However, the catheterization of thoracic epidural space in such low-risk patients has many logistic issues.

Up to the best of our knowledge, there is no available comparative randomized clinical trial compares the use of continuous and patient-controlled lumbar epidural analgesia after UAE.

Conditions

  • Uterine Artery Embolization for Uterine Leiomyomata

Interventions

PROCEDURE

Patient-controlled epidural analgesia

Patients will receive with patient controlled background infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl that will be set between 4-6 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm), intermittent bolus of 10 ml on demand by the women with lockout interval of 20 min with a four-hour maximum dose of 100 mL, irrespective of their age. The epidural infusions will be maintained for the first 24 postoperative hours

PROCEDURE

Continuous epidural analgesia

Patients will receive continuous epidural infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl at rate of 6-15 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm).

Sponsors & Collaborators

  • Imam Abdulrahman Bin Faisal University

    lead OTHER

Principal Investigators

  • Bander F Aldhafery, MD · Chairman of Radiology Dept

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-05-31
Completion
2019-06-30

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02236585 on ClinicalTrials.gov