Analgesia Effects of Nalbuphine vs Sulfentanil
キーワード
概要
説明
Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists.
Opiate drugs constitute the baseline medication for postoperative analgesia. However, pure μ opioid receptor agonist like morphine and fentanyl may induce adverse effects such as nausea, vomiting, dizziness, drowsiness and respiratory depression. Nalbuphine hydrochloride is an opiate-like substance structure-related oxymorphone, which is a κ receptor agonist/μ receptor partial antagonistic type analgesia drug. Specific κ receptor agonist and gene knockout experiment reveals that κ receptor agonist depresses the visceral pain induced by chemical stimulation, the effect of which outperforms pure μ opioid receptor agonist. Studies have discovered that some κ receptor agonists can reduce or inhibit the side effects of μ receptor agonist such as tolerance or dependence. The adverse effects of μ receptor agonist such as pruritus, nausea, vomiting, delayed gastric emptying are caused by the drug on peripheral opioid receptor, and can be relieved by opioid receptor agonist. The structure of nalbuphine hydrochloride is related to naloxone, an opioid receptor antagonist, therefore, the incidence of adverse effects of nalbuphine hydrochloride is lower than that of μ receptor agonist. In recent years, nalbuphine hydrochloride has become more and more popular in postoperative analgesia. There has been reports on intrathecal administration of nalbuphine hydrochloride for analgesia after cesarean section, while the effect of intravenous administration of nalbuphine hydrochloride on analgesia after cesarean section remains undetermined. This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.
日付
最終確認済み: | 09/30/2015 |
最初に提出された: | 10/25/2015 |
提出された推定登録数: | 11/10/2015 |
最初の投稿: | 11/12/2015 |
最終更新が送信されました: | 11/10/2015 |
最終更新日: | 11/12/2015 |
実際の研究開始日: | 12/31/2015 |
一次完了予定日: | 12/31/2016 |
研究完了予定日: | 12/31/2017 |
状態または病気
介入/治療
Drug: Nalbuphine
Drug: Sufentanil
Drug: flurbiprofen axetil
Drug: ramosetron
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: Nalbuphine Nalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation. | Drug: Nalbuphine patient-controlled intravenous analgesia |
Experimental: Sufentanil Sufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation. | Drug: Sufentanil patient-controlled intravenous analgesia |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | Female |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - For primipara with selective cesarean section Exclusion Criteria: - Severe preeclampsia, - pregnancy complicated with diabetes mellitus - pregnancy complicated with cardiac disease, - gestation age<37W - recently use of opiate drugs or nonsteroidal antiinflammatory drugs within 48 h before operation |
結果
主な結果の測定
1. Pain scores of nalbuphine group [up to 24 months]
2. Pain scores of sufentanil group [up to 24 months]
二次的な結果の測定
1. Usage of nalbuphine of nalbuphine group [up to 24 months]
2. Usage of sufentanil of sufentanil group [up to 24 months]