Comparison of Efficacy and Safety of the Postoperative Analgesia Methods
Summary
An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. In a previous study, the investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in the previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study the investigators will use different doses of morphine based PCA and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy.
Timeline
- Start
- 2016-11
- Primary completion
- 2017-11
- Completion
- 2017-11
Publications
- Background Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4.
- Background Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
- Background Garah J, Adiv OE, Rosen I, Shaoul R. The value of Integrated Pulmonary Index (IPI) monitoring during endoscopies in children. J Clin Monit Comput. 2015 Dec;29(6):773-8. doi: 10.1007/s10877-015-9665-z. Epub 2015 Feb 11.
- Akcil EF, Korkmaz Dilmen O, Ertem Vehid H, Yentur E, Tunali Y. The role of "Integrated Pulmonary Index" monitoring during morphine-based intravenous patient-controlled analgesia administration following supratentorial craniotomies: a prospective, randomized, double-blind controlled study. Curr Med Res Opin. 2018 Nov;34(11):2009-2014. doi: 10.1080/03007995.2018.1501352. Epub 2018 Aug 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexketoprofen | Small molecule | 50 mg | Intravenous |
| Subject | Morphine | Other / unclassified | 0.5 mg | — |
| Subject | Morphine | Other / unclassified | 1 mg | — |