Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The onset of pain
研究概览
简要总结
Total knee replacement is one of the most painful orthopedic surgical procedures. Patients who undergo total knee replacement are usually older and have limited cardiac and pulmonary reserves. The increased sensitivity of elderly patients to drugs makes it necessary to choose postoperative analgesia agents and methods that have minimal side effects.
Intrathecal injection of morphine to provide postoperative analgesia during the initial 24-h after the operation is a widely used technique, however, opioid therapy is limited because of the side effects (hypotension, pruritus, nausea, urinary retention, respiratory depression) and intolerance.
Alpha-2 adrenergic agonists (clonidine and dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia.
Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system.
The rationale for combining analgesics that produce similar therapeutic effects or synergistic interactions is to accentuate the analgesic efficacy and decrease the side effects by permitting dose reduction of each agent. Human studies on the antinociceptive effects of co-administrated intrathecal morphine (ITM) and dexmedetomidine in postoperative pain are still few.
On the other hand, Abdel-Ghaffar et al., results do not support improved analgesia with the combination of intrathecal morphine and dexmedetomidine, despite the absence of significant adverse effects.
We hypothesized that the addition of dexmedetomidine to ITM would improve the quality of perioperative pain control and decrease the side effects of postoperative systemic opioid use.
详细描述
105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia will be included in this study.
105 Patients will be randomly allocated into three equal groups (35 patients each):
- Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
- Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine
Measurements:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia
排除标准
- •Patients who had bleeding disorders
- •Patients who had heart, liver, or renal failure
- •Patients who had systemic infections or infections of their injection sites
- •Patients with a known allergy to study
- •Patients who had 2nd or 3rd-degree heart block
- •Those with low back pain or other back problems
- •History of drug or alcohol abuse
- •Body mass index (BMI) > 30 kg\m2
- •Patients with psychiatric illnesses that would interfere with perception and assessment of pain.
研究组 & 干预措施
Group Dex
Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
Group morphine
Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
干预措施: Morphine (Drug)
Group morphine-Dex
Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
Group morphine-Dex
Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
干预措施: Morphine (Drug)
结局指标
主要结局
The onset of pain
时间窗: upto 24 hours postoperative
The onset of pain is defined as VAS ≥ 4 within 24 hours
次要结局
- Postoperative complications(upto 24 hours postoperative)
- Postoperative pain severity(upto 24 hours postoperative)
- The amount of additional analgesic required(upto 24 hours postoperative)
研究者
Amany Faheem
Assistant professor of anesthesiology, intensive care, and pain medicine
Tanta University