drugset / Trial / NCT06951802
Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine
RandomizedParallel-groupSingle-blindTreatment
Summary
RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome
Timeline
- Start
- 2024-12-03
- Primary completion
- 2025-06-30
- Completion
- 2026-12-31
Publications
- Background Kanellos P, Nirgianakis K, Siegenthaler F, Vetter C, Mueller MD, Imboden S. Postoperative Pain Is Driven by Preoperative Pain, Not by Endometriosis. J Clin Med. 2021 Oct 15;10(20):4727. doi: 10.3390/jcm10204727.
- Background Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril. 2004 Oct;82(4):878-84. doi: 10.1016/j.fertnstert.2004.03.046.
- Background Chiuve SE, Kilpatrick RD, Hornstein MD, Petruski-Ivleva N, Wegrzyn LR, Dabrowski EC, Velentgas P, Snabes MC, Bateman BT. Chronic opioid use and complication risks in women with endometriosis: A cohort study in US administrative claims. Pharmacoepidemiol Drug Saf. 2021 Jun;30(6):787-796. doi: 10.1002/pds.5209. Epub 2021 Mar 16.
- Background Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.
- Background Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.
- Background Cappellini MD, Comin-Colet J, de Francisco A, Dignass A, Doehner W, Lam CS, Macdougall IC, Rogler G, Camaschella C, Kadir R, Kassebaum NJ, Spahn DR, Taher AT, Musallam KM; IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068-1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7.
- Background World Health Organization. (2021). Anaemia in women and children. The Global Health Observatory. Retrieved July 4, 2022, from. https://www.who.int/data/gho/data/themes/topics/anaemia_ in_women_and_children
- Background Gete DG, Doust J, Mortlock S, Montgomery G, Mishra GD. Risk of Iron Deficiency in Women With Endometriosis: A Population-Based Prospective Cohort Study. Womens Health Issues. 2024 May-Jun;34(3):317-324. doi: 10.1016/j.whi.2024.03.004. Epub 2024 Apr 24.
- Background Maddern J, Grundy L, Castro J, Brierley SM. Pain in Endometriosis. Front Cell Neurosci. 2020 Oct 6;14:590823. doi: 10.3389/fncel.2020.590823. eCollection 2020.
- Background Wyatt J, Fernando SM, Powell SG, Hill CJ, Arshad I, Probert C, Ahmed S, Hapangama DK. The role of iron in the pathogenesis of endometriosis: a systematic review. Hum Reprod Open. 2023 Jul 27;2023(3):hoad033. doi: 10.1093/hropen/hoad033. eCollection 2023.
- Background Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
- Background Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.
- Background Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
- Background Shirvalkar P, Prosky J, Chin G, Ahmadipour P, Sani OG, Desai M, Schmitgen A, Dawes H, Shanechi MM, Starr PA, Chang EF. First-in-human prediction of chronic pain state using intracranial neural biomarkers. Nat Neurosci. 2023 Jun;26(6):1090-1099. doi: 10.1038/s41593-023-01338-z. Epub 2023 May 22.
- Vetter C. Opioid-sparing by low-dose ketamine for endometriosis surgery. A single-center, prospective, randomized, trial. Pain Manag. 2026 Apr;16(4):271-276. doi: 10.1080/17581869.2026.2613800. Epub 2026 Jan 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | — | — |
| Background | Propofol | Small molecule | — | — |