Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The postoperative analgesic duration
研究概览
简要总结
Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.
详细描述
This is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. The investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pressuerization on the postoperative analgesia.
All patients will receive spinal anesthesia aiming for at least T12-L1 level. Postoperative standard analgesia will be paracetamol and diclofenac, given for both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
An anesthetist, not involved in the study, was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drugs. The patient and the data collectors (anesthesia resident) does not know the group assignment.
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I or II
- •Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia
排除标准
- •Pregnant females
- •Body mass index ≥ 35 kg/m2
- •Allergy to ketorolac
- •Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias
- •Had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides
- •Edema in the operated limb grade ≥ 3
研究组 & 干预措施
control
will receive 50 ml normal saline in the intravenous regional cannula in the surgical limb with torniquet.
And receive intravenous 30 mg ketorolac diluted in 10 ml saline in the peripheral general circulation.
干预措施: Control (Other)
ketorolac
will receive 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml in the intravenous regional cannula in the surgical limb with torniquet.
And receive intravenous 10 ml saline in the peripheral general circulation.
干预措施: Ketorolac (Drug)
结局指标
主要结局
The postoperative analgesic duration
时间窗: within 24 hours after the surgery
the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient
次要结局
- time to sensory recovery from spinal anesthesia(through the intraoperative or postoperative care unit)
- time to motor recovery from spinal anesthesia(through the intraoperative or postoperative care unit)
- Postoperative pain at rest(at 2, 4, 6, 12, 24 hours after 24 hours after surgery)
- Postoperative pain at movement(at 2, 4, 6, 12, 24 hours after 24 hours after surgery)
- Total postoperative analgesic consumption(within the first 24 hours after surgery)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University