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Sustained released oxycodone/naloxone for postoperative pain therapy after caesarean section - Oxycodone post caesaream

niversitätsklinikum Schleswig-Holstein,Campus Kiel,Klinik für Anästhesiologie und Operative Intensivmedizin0 个研究点目标入组 143 人开始时间: 2016年12月5日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
143

研究概览

简要总结

Postoperative pain management after Caesarean Section (CS) is still insufficient and the unfavourable outcome is mainly associated with low opioid administration after CS [1]. Since sustained released oxycodone/naloxone is recommended for postoperative pain therapy after abdominal surgery [2], we evaluated a postoperative pain therapy concept based on this drug combination. Methods: After IRB approval we compared the prior established postoperative pain therapy scheme of our institution after CS with a new scheme based on sustained released oxycodone/naloxone in an observational study. In the prior established group all patients received sustained released ibuprofen (800 mg) for 3 day after CS and further analgesics on demand. In the oxycodone group patients received additionally Targin® 20/10 (20 mg oxycodone / 10 mg naloxone, sustained release) immediately after CS and Targin® 10/5 12h later and 10 mg oxycodone on demand. All patients completed a questionnaires 24h and 48h after CS containing questions about the intensity of pain (min, max, rest and incident pain), the interference of pain with mobilization and coughing, wish for more analgesics, other symptoms related to pain (sleep quality, mood, fatigue, nausea and vomiting) and the overall satisfaction with the pain therapy. Results: In each group 70 patients completed the questionnaires after CS in regional anaesthesia. In the “prior established” group 68/70 patients received ibuprofen 1600mg), 42 additionally paracetamol (2-4g), 13 patients piritramid (7.5-15 mg, comparable to 5-12.5 mg morphine) and 2 patients diclofenac (75 mg) in the first 24h. In the oxycodone group all patients received 30 mg Targin® and 1600 mg ibuprofen, 21 patients additionally oxycodone (10-20 mg) and 26 patients paracetamol (1g) in the first 24h. We found no differences in any of the parameters of pain intensity or other collected parameters neither 24h nor 48 h postoperative. The medians for rest pain and incident pain were >3 and >6 in both groups, the median interference of pain with mobilisation and coughing was “high” in both groups 24h postoperative . Conclusion: In this setting sustained released oxycodone did not influence the postoperative pain therapy after CS compared to a nearly opioid-free postoperative pain therapy. In both groups the postoperative pain therapy was insufficient. References: 1. Marcus, H., et al., Quality of pain treatment after caesarean section: Results of a multicentre cohort study. Eur J Pain, 2014. 2. Englbrecht, J.S. and E.M. Pogatzki-Zahn, [Perioperative pain management for abdominal and thoracic surgery]. Schmerz, 2014. 28(3): p. 265-81.

研究设计

研究类型
Interventional
分配方式
Non-randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
Female

入选标准

  • Age >18 years < 50 years
  • - (ASA Physical Status I-III, classification der American Society of Anesthesiologists, 1963)
  • - primary or secondary caesarean in spinal or epidural anesthesia
  • - german language
  • - informend consent

排除标准

  • - Oxycodone / Ibuprofen /Paracetamol Allergy
  • - preexisting chronic pain conditions
  • - medication with opioid (substitution program)

研究者

发起方
niversitätsklinikum Schleswig-Holstein,Campus Kiel,Klinik für Anästhesiologie und Operative Intensivmedizin

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