Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Postoperative Opioid Requirement After Mastectomy
研究概览
简要总结
This study will compare the effects of oral pregabalin with placebo on postoperative pain and morphine usage after mastectomy.
Pregabalin is an anticonvulsant agent approved by the United States Food and Drug Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy.
Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with axillary node dissection will be recruited to participate in the study. Patients unable to cooperative, those that have known allergy to pregabalin or morphine and a history of drug or alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or impaired kidney function will all be excluded from the study. A pregnancy test will also be performed to exclude pregnant women from the study.
Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before surgery followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or placebo) will be administered twice daily until day 14. Whether a patient receives pregabalin or placebo will be decided based on a process similar to tossing a coin.
Patients will receive a standard general anesthetic for their operation and will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. Oral opioids will be administered after discontinuation of the PCA.
Subjects will be visited after the operation while in the hospital and intermittently for three months at the outpatient clinic after discharge from the hospital. Subjects will be asked to return remaining study drug/empty container when they are at the hospital for their 2 week follow up visit.
Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema, weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side effects occurring ranges variously between 1 and 25%. Investigators will closely monitor all patients for the occurrence of these side effects.
详细描述
TITLE: The Effects of Oral Pregabalin versus Placebo on Postoperative Pain and Morphine Consumption after Mastectomy
INVESTIGATOR: Babatunde O. Ogunnaike, MD. Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas, Texas
RATIONALE: In recent years, persistent pain after surgical procedures has been recognized as a major factor delaying recovery and return to normal daily living. Long-lasting pain has been reported after numerous surgical procedures including mastectomy. The prevalence of persistent post-mastectomy pain has been quoted to be anywhere from 40% to 80% and may substantially impact the life of patients treated for cancer (Smith et al. Pain 1999; 83: 91-5). Peripheral and central sensitization after tissue and nerve injury have been implicated in the development of more intractable pain that potentially can become chronic (Joshi & Ogunnaike, Anesthesiology Clin N Am 2005; 23: 21-36) Gabapentin, an anticonvulsant widely used for the treatment of chronic pain, has been shown to decrease neuropathic pain (Rice & Maton, Pain 2001; 94: 215-24) Dirks et al. (Anesthesiology 2002; 97: 560) reported that gabapentin 1200 mg prior to surgery reduced postoperative morphine requirements and movement-related pain after radical mastectomy. However, the immediate as well as long-term benefits of the drug were not evaluated in their study. Fassoulaki et al. (Anesth Analg 2002; 95: 985-91) also observed that pain at rest and movement pain were both reduced by gabapentin in the early postoperative period. Pregabalin is a new anticonvulsant agent recently approved by the FDA for the treatment of neuropathic pain associated with post-herpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) [Gajraj NM. Pain Practice 2005; 5: 95-102]. This study is designed to evaluate the analgesic efficacy of pregabalin after mastectomy.
OBJECTIVES:
Primary: To evaluate the effects of pregabalin on postoperative opioid requirements and opioid-related side effects Secondary: To evaluate the effects of pregabalin on pain scores at 3 months after mastectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, 18-70 years of age
- •ASA physical status I to III
- •Undergoing unilateral modified radical mastectomy or lumpectomy with axillary node dissection
排除标准
- •Patients unable to cooperate
- •Have known allergy to pregabalin or morphine
- •A history of drug or alcohol abuse
- •History of chronic pain
- •Daily intake of analgesics or steroids
- •Impaired kidney function
研究组 & 干预措施
pregabalin
pregabalin (lyrica)
干预措施: lyrica (Drug)
placebo
placebo
干预措施: lyrica (Drug)
结局指标
主要结局
The Postoperative Opioid Requirement After Mastectomy
时间窗: Participants received PCA pump, an average of 24 hrs after mastectomy
IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy
Oral Opioids Consumption
时间窗: Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy
Oral opioids consumption after mastectomy until hospital discharge.
次要结局
- Pain Scores(Participants' pain score was assessed after discharge on the 90th day after mastectomy)
研究者
Babatunde Ogunnaike
MD
University of Texas Southwestern Medical Center