Patient-Controlled Epidural Analgesia After Uterine Artery Embolization

NCT02236585 | Unknown DMC

• 2 other identifiers: UD-2015-16-P2AnesthGPAnesth-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

uterine artery embolization, epidural , patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Cumulative consumption of bupivacaine-fentanyl

  The cumulative consumption of bupivacaine-fentanyl for 24 hours after uterine artery embolization (UAE) will be recorded

  24 hours after procedure

Secondary Outcomes (6)

• Quality of analgesia

  every 2 hours intervals after uterine artery embolization

• Time for first request for rescue analgesia

  6 hours after surgery

• Number of supplementary top-up doses required

  24 hours after surgery

• Cumulated amounts of local anesthetic consumption

  24 hours after procedure

• Overall patient satisfaction

  24 hours after surgery

Study Arms (2)

Patient-controlled epidural analgesia

ACTIVE COMPARATOR

Patient-controlled epidural analgesia

Procedure: Patient-controlled epidural analgesia

Continuous epidural analgesia

PLACEBO COMPARATOR

Continuous epidural analgesia

Procedure: Continuous epidural analgesia

Interventions

Patient-controlled epidural analgesia PROCEDURE

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

Patient-controlled epidural analgesia

Continuous epidural analgesia PROCEDURE

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).

Continuous epidural analgesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Routine elective uterine artery embolization
• uterine leiomyomata
• Epidural anesthesia

You may not qualify if:

• Cardiac disorder
• Pulmonary disorder
• Renal disorder
• Hepatic disorder
• Neuropsychiatric disorder
• Bleeding disorder
• Severe anatomical abnormalities of the vertebral column
• Contraindications to epidural analgesia
• Preoperative pain score \> 70 mm
• Drug abuse
• Daily intake of analgesics
• Language or mental disorders

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (2)

King Fahd Hospital of Dammam University

Khobar, Eastern Province, 31592, Saudi Arabia

RECRUITING

King Fahd Hospital of the University

Khobar, Eastern Province, 31952, Saudi Arabia

RECRUITING

Study Officials

• Bander F Aldhafery, MD

  Chairman of Radiology Dept

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed R El Tahan, MD

CONTACT

+966 13 865 1193; mohamedrefaateltahan@yahoo.com

Abdulmohsin A Al Ghamdi, MD

CONTACT

+966 50 581 4737; mohsenkfu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

SA (2)