CTRI/2019/09/021200已完成3 期
A Randomized, Open-label, Prospective, Comparative, Multi-centre, Parallel group, Active controlled, Phase III Study to Evaluate the Efficacy and Safety of the Ropivacaine Readyfusor 2mg/ml versus Ropivacaine Balloon Pump Infusor 2mg/ml as a continuous surgical site infusion for the Treatment of Post-Surgical Pain in lower abdominal laparotomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Participant or participantââ?¬•s legally acceptable representative is willing and able to give informed consent
- •2. Subjects of either gender with age 18 to 65 years (both inclusive) scheduled for lower abdominal surgery
- •3. Patient scheduled to undergo lower abdominal laparotomy surgery with requirement of hospitalization for at least 3 days
- •4. The length of surgical site incision should be around 15Ã?±3cms
- •5. Able and willing to comply with all study requirements
- •6. Subject doesnââ?¬•t suffer from any significant co-morbidity which in the opinion of the investigator renders the patient unfit for the studyââ?¬• American Society of Anesthesiologists [ASA] I-II
排除标准
- •1. History of allergy to study related drug, which would preclude all the possible combinations, capable of providing usual care multimodal analgesia: other local anesthetics, morphine, oxycodone, fentanyl, paracetamol
- •2. Body weight < 50 kg or a body mass index ââ?°Â¥ 40 kg/m2
- •3. Clinically significant illness or surgery within 1 week prior to screening visit (including flu, flu like symptoms, diarrhea, vomiting, ongoing sepsis/bacterial infections)
- •4. Any skin lesion/abnormality at site of catheterization
- •5. Chronic pain, with or without long-term regular analgesic usage
- •6. History of substance abuse
- •7. Pregnant or breast-feeding females
- •8. Participants not able to discontinue the prohibited medications listed in the protocol within the allotted time before surgery and throughout their duration of participation in the study
- •Ã¢â?¬Â¢ Monoamine oxidase inhibitors within the past 30 days
- •Ã¢â?¬Â¢ Anticonvulsants, tricyclic antidepressants (TCAs), neuroleptics, serotonin-norepinephrine reuptake inhibitors (SNRIs), as well as selective serotonin reuptake inhibitors (SSRIs; unless SSRIs have been prescribed for depression and/or anxiety and patients have been on a stable dose for at least 30 days prior to the screening visit)
- •Ã¢â?¬Â¢ Corticosteroids: Oral and injectable corticosteroids must be discontinued 3 months prior to surgery; nasal, inhaled and topical corticosteroids will be allowed
- •9. Patients who have participated in any clinical trial within past 12 weeks
- •10. Chronic, high-dose opioid use (greater than 20 mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use > 4 weeks)
- •11. Concurrent painful physical conditions that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the lower abdominal surgery of this study as pain from these conditions may confound postsurgical assessments
- •12. Any opioid medications, NSAIDs, or aspirin (except for low-dose aspirin used for cardioprotection) within 24 hours of study drug administration
- •13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participantââ?¬•s ability to participate in the study
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