D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinary Retention

Официальное название

Comparison of Intrathecal Dexmedetomidine Versus Intrathecal Fentanyl as Adjuvants to Bupivacaine on Post-Operative Urinary Retention in Lower Limb Surgery

Обзор

This study aims to compare two medications, dexmedetomidine and fentanyl, when used alongside a commonly used spinal anesthetic called bupivacaine in patients undergoing lower limb surgery. The main focus of the study is to see which combination causes fewer problems with urination after surgery - a condition known as postoperative urinary retention (POUR). POUR can lead to discomfort, delayed recovery, and a need for catheterization. Dexmedetomidine is a newer drug that may help reduce this problem compared to fentanyl, which is more commonly used but may increase the risk of urinary retention. This trial will help determine which medication combination provides better pain relief while reducing urinary side effects. The study is being conducted as a randomized, double-blind trial at a hospital in Nepal and will include 190 adult patients. \-

Подробное описание

Spinal anaesthesia is a common and effective method used to manage pain during lower limb surgeries. It allows patients to remain awake and comfortable while providing excellent pain control. To make spinal anaesthesia last longer and provide better pain relief, certain medications called adjuvants are added to the main anaesthetic drug, bupivacaine. Two commonly used adjuvants are fentanyl, an opioid, and dexmedetomidine, a medication that works on the body's alpha-2 receptors to provide sedation and pain relief.

However, a known side effect of spinal anaesthesia especially when combined with certain adjuvants is postoperative urinary retention (POUR). This condition occurs when a patient is unable to urinate normally after surgery. POUR can be uncomfortable, may delay recovery, and often requires insertion of a urinary catheter, which can increase the risk of infection and hospital stay.

This clinical trial, called the D-FAB POUR Trial, is designed to find out which of these two adjuvants dexmedetomidine or fentanyl is more likely to cause or prevent POUR when used with bupivacaine in patients undergoing elective lower limb surgery.

The study will involve 190 adult patients. Each participant will receive spinal anaesthesia with bupivacaine and be randomly assigned to also receive either dexmedetomidine or fentanyl. Neither the patients nor the doctors will know which medication is given in a process known as double-blinding to ensure fairness and eliminate bias.

The researchers will monitor the ability of patients to urinate at the third and sixth hours after surgery, using ultrasound to measure bladder volume. If the patient is unable to pass urine and the bladder is overly full, temporary or longer-term catheterisation may be needed. These outcomes will help determine how each drug affects bladder function.

In addition to urinary outcomes, the study will also look at side effects like nausea, vomiting, itching, changes in blood pressure or heart rate, sedation level, and how much extra pain relief the patient needs after surgery.

The goal of this research is to help doctors choose the best adjuvant to use in spinal anaesthesia, one that provides effective pain control without increasing the risk of urinary problems. The findings may lead to improved safety, comfort, and recovery for patients undergoing lower limb operations.

Вмешательства

• Препарат Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine
  Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine Detailed Description: This intervention consists of a single intrathecal injection of 10 micrograms of dexmedetomidine combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anaesthesia for lower limb surgery. The total volume administered is 3.5 mL. Dexmedetomidine is an alpha-2 non-opioid adjuvant used as a spinal adjuvant for enhancing analgesia
• Препарат Intervention 2: Intrathecal Fentanyl with Bupivacaine
  This intervention consists of a single intrathecal injection of 25 micrograms of fentanyl combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anesthesia for lower limb surgery. The total volume administered is 3.5 mL. Fentanyl is a lipophilic opioid commonly used as a spinal adjuvant for enhancing analgesia. This arm is being compared with dexmedetomidine to evaluate differences in POUR incidence, analgesic effectiveness, and side effect profiles.

Первичные конечные точки

• Incidence of Postoperative Urinary Retention (POUR) at the 3rd Postoperative Hour [Срок оценки: 3 hours after spinal anesthesia]

Вторичные конечные точки (1)

• Requirement of Urinary Catheterization at 6th Postoperative Hour [Срок оценки: 6 hours after spinal anesthesia]

Критерии участия

Критерии включения

• Adults aged 18 to 60 years
• Scheduled for elective lower limb surgery under spinal anesthesia
• Classified as American Society of Anesthesiologists (ASA) physical status II or III
• Minimum height of 150 cm (to ensure uniform drug volume)
• Able to understand the study procedures and provide written informed consent (in English or Nepali)

Критерии исключения

• Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site, hemodynamic instability)
• Known allergy or hypersensitivity to bupivacaine, fentanyl, or dexmedetomidine
• Chronic pain conditions or long-term opioid use
• Neurological, Cardiac, Renal, or uncontrolled diabetic conditions
• Current treatment for prostatic pathology or use of alpha-2 blockers
• Presence of a Foley's catheter preoperatively
• Estimated surgical duration: >2.5 hours
• Inability or unwillingness to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Nepal · 1 центр

• Om Sai Pathibhara Hospital — Bhadrapur

Идентификаторы

NCT: NCT07117565 · D-FAB-POUR Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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