Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy

Summary

Postoperative pain affects 80% of surgical patients and is one of the main negative symptoms resulting from surgery. It impairs the recovery of patient since it is related to chronic pain, nausea and vomiting and longer hospital stay, generating higher cost to the health system. Thus, the use of new methods to control postoperative pain is recommended and multimodal analgesia, an opioid-sparing strategies, has been widely used by several researchers. Studies show that gabapentins have beneficial effects on postoperative pain control when used as pre-anesthetic medication, also showing a reduction in opioid consumption, with few adverse effects. Among gynecological surgeries, abdominal hysterectomy is one of the procedures that generates the highest degree of acute postoperative pain. Thus, the aim of the present study is to investigate the effect of oral pregabalin (300 mg) two hours before abdominal hysterectomy procedures on postoperative pain. This study is a randomized, double-blind, placebo controlled clinical trial. Patients submitted to abdominal hysterectomy for benign pathologies will be selected and divided into two groups: the placebo controlled group (P0) and the pregabalin 300 mg group (P1). Group P0 will receive a placebo tablet one hour before the procedure, while group P1 will receive a 300 mg tablet of pregabalin identical to the placebo tablet. The reduction of postoperative pain and the best quality of patient recovery will be evaluated using the Visual Analogue Pain Scale (VAS) and the McGill Pain Questionnaire. Also, it will be evaluated the consumption of opioids as a rescue analgesic medication and the presence of adverse effects such as nausea and vomiting.

Timeline

Start

2019-09-02

Primary completion

2020-09-09

Completion

2020-09-30

Publications

• Background Hu J, Huang D, Li M, Wu C, Zhang J. Effects of a single dose of preoperative pregabalin and gabapentin for acute postoperative pain: a network meta-analysis of randomized controlled trials. J Pain Res. 2018 Nov 2;11:2633-2643. doi: 10.2147/JPR.S170810. eCollection 2018.
• Background As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268. doi: 10.1097/AOG.0000000000002344.
• Background Farzi F, Naderi Nabi B, Mirmansouri A, Fakoor F, Atrkar Roshan Z, Biazar G, Zarei T. Postoperative Pain After Abdominal Hysterectomy: A Randomized, Double-Blind, Controlled Trial Comparing the Effects of Tramadol and Gabapentin as Premedication. Anesth Pain Med. 2016 Jan 17;6(1):e32360. doi: 10.5812/aapm.32360. eCollection 2016 Feb.
• Background Ghai A, Gupta M, Hooda S, Singla D, Wadhera R. A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy. Saudi J Anaesth. 2011 Jul;5(3):252-7. doi: 10.4103/1658-354X.84097.
• Background Kohli M, Murali T, Gupta R, Khan P, Bogra J. Optimization of subarachanoid block by oral pregabalin for hysterectomy. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):101-5.
• Background Main CJ. Pain assessment in context: a state of the science review of the McGill pain questionnaire 40 years on. Pain. 2016 Jul;157(7):1387-1399. doi: 10.1097/j.pain.0000000000000457.
• Background Steinberg AC, Schimpf MO, White AB, Mathews C, Ellington DR, Jeppson P, Crisp C, Aschkenazi SO, Mamik MM, Balk EM, Murphy M. Preemptive analgesia for postoperative hysterectomy pain control: systematic review and clinical practice guidelines. Am J Obstet Gynecol. 2017 Sep;217(3):303-313.e6. doi: 10.1016/j.ajog.2017.03.013. Epub 2017 Mar 27.
• Background Tulandi T, Krishnamurthy S, Mansour F, Suarthana E, Al-Malki G, Ballesteros LER, Moore A. A Triple-Blind Randomized Trial of Preemptive Use of Gabapentin Before Laparoscopic Hysterectomy for Benign Gynaecologic Conditions. J Obstet Gynaecol Can. 2019 Sep;41(9):1282-1288. doi: 10.1016/j.jogc.2018.11.019. Epub 2019 Jan 25.
• Background Verret M, Lauzier F, Zarychanski R, Savard X, Cossi MJ, Pinard AM, Leblanc G, Turgeon AF. Perioperative use of gabapentinoids for the management of postoperative acute pain: protocol of a systematic review and meta-analysis. Syst Rev. 2019 Jan 16;8(1):24. doi: 10.1186/s13643-018-0906-3.
• Background Yucel A, Ozturk E, Aydogan MS, Durmus M, Colak C, Ersoy MO. Effects of 2 different doses of pregabalin on morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind clinical trial. Curr Ther Res Clin Exp. 2011 Aug;72(4):173-83. doi: 10.1016/j.curtheres.2011.06.004.

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