Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China
Introduction Postoperative pain has always been a problem for patients and surgeons. Local inflammation, surgical trauma and pain in the body can cause a systemic stress response and immune imbalance, which can affect the patient’s rapid recovery. Currently, most of the perioperative pain management...
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e069187.full |
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| author | Yong Liu Wei Han Xinyu Zhao Jinhong Gao Shaolong Hao Yibing Weng |
| author_facet | Yong Liu Wei Han Xinyu Zhao Jinhong Gao Shaolong Hao Yibing Weng |
| author_sort | Yong Liu |
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| description | Introduction Postoperative pain has always been a problem for patients and surgeons. Local inflammation, surgical trauma and pain in the body can cause a systemic stress response and immune imbalance, which can affect the patient’s rapid recovery. Currently, most of the perioperative pain management is focused on the postoperative phase. The non-steroidal anti-inflammatory drug indomethacin suppository has antipyretic and analgesic effects. This study will evaluate the value of indomethacin suppository for analgesia and anti-inflammation before laparoscopic appendectomy (LA).Methods and analysis A single-centre, double-blinded (clinician, assessor, data entry), randomised controlled trial will be conducted in 128 adult patients undergoing LA under emergency general anaesthesia with a Visual Analogue Scale (VAS) >2. The trial was divided into two groups (n=64) using a randomised number table: group A will be given 100 mg of indomethacin suppository rectally and group B will be given 8 mg of intravenous lornoxicam. The postoperative analgesic effect, inflammatory response and incidence of postoperative adverse effects will be compared.Ethics and dissemination The study is in accordance with the Declaration of Helsinki and will be conducted in accordance with the principles of Good Clinical Practice. This trial was approved by the Ethics Committee of Beijing Luhe Hospital, Capital Medical University (2021-LHKY-123-02). We will disseminate our study findings at national and international paediatric research conferences.Trial registration number Chinese Clinical Trial Registry (ChiCTR2200062004). |
| format | Article |
| id | doaj-art-64767b00081b4a49808df4d15bfa7ee1 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-64767b00081b4a49808df4d15bfa7ee12024-11-14T13:10:07ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2022-069187Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in ChinaYong Liu0Wei Han1Xinyu Zhao2Jinhong Gao3Shaolong Hao4Yibing Weng5Institute of High Performance Computing, Agency for Science, Technology and Research, SingaporeDepartment of General Surgery, Beijing Luhe Hospital, Capital Medical University, Beijing, ChinaDepartment of General Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of General Surgery, Beijing Luhe Hospital, Capital Medical University, Beijing, ChinaDepartment of General Surgery, Beijing Luhe Hospital, Capital Medical University, Beijing, ChinaDepartment of Intensive Care Unit, Beijing Luhe Hospital, Capital Medical University, Beijing, ChinaIntroduction Postoperative pain has always been a problem for patients and surgeons. Local inflammation, surgical trauma and pain in the body can cause a systemic stress response and immune imbalance, which can affect the patient’s rapid recovery. Currently, most of the perioperative pain management is focused on the postoperative phase. The non-steroidal anti-inflammatory drug indomethacin suppository has antipyretic and analgesic effects. This study will evaluate the value of indomethacin suppository for analgesia and anti-inflammation before laparoscopic appendectomy (LA).Methods and analysis A single-centre, double-blinded (clinician, assessor, data entry), randomised controlled trial will be conducted in 128 adult patients undergoing LA under emergency general anaesthesia with a Visual Analogue Scale (VAS) >2. The trial was divided into two groups (n=64) using a randomised number table: group A will be given 100 mg of indomethacin suppository rectally and group B will be given 8 mg of intravenous lornoxicam. The postoperative analgesic effect, inflammatory response and incidence of postoperative adverse effects will be compared.Ethics and dissemination The study is in accordance with the Declaration of Helsinki and will be conducted in accordance with the principles of Good Clinical Practice. This trial was approved by the Ethics Committee of Beijing Luhe Hospital, Capital Medical University (2021-LHKY-123-02). We will disseminate our study findings at national and international paediatric research conferences.Trial registration number Chinese Clinical Trial Registry (ChiCTR2200062004).https://bmjopen.bmj.com/content/13/8/e069187.full |
| spellingShingle | Yong Liu Wei Han Xinyu Zhao Jinhong Gao Shaolong Hao Yibing Weng Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China BMJ Open |
| title | Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China |
| title_full | Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China |
| title_fullStr | Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China |
| title_full_unstemmed | Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China |
| title_short | Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China |
| title_sort | value of indomethacin suppository for preoperative analgesia and anti inflammation in laparoscopic appendectomy a protocol of prospective double blinded single centre randomised controlled trial in china |
| url | https://bmjopen.bmj.com/content/13/8/e069187.full |
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