Gynecologic Disease Clinical Trial
Official title:
Effect of Two Different Doses of Oral Pregabalin Premedication for Postoperative Pain Relief After Gynecological Surgeries
Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression. Previous studies stated that pregabalin has been used to reduce pre-operative anxiety, acute postoperative pain, postoperative opioid requirements, postoperative nausea, vomiting and postoperative delirium. The most effective dose of pregabalin to relief postoperative pain with least side effect is still under trial. In this study we will compare between two different doses of pregabalin when given as oral premedication in patients undergoing gynecological surgeries under spinal anesthesia regarding postoperative pain in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | November 2021 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: - Physical status: ASA I-II - BMI = 20kg/m2 & = 35kg/m2, - Written informed consent from the patient. Exclusion Criteria: - Patients with known history of allergy to study drugs, - Patients on ACE inhibitors, anticonvulsant therapy or any drug interacting with pregabalin, - Patients on chronic alcohol, opioid, tranquilizer or sedative use, - Patient with renal impairment or heart failure, - Pregnant females, Psychological, mental disorders or depression, - Patients receiving anticoagulants therapy or suspected coagulopathy, - Patients already on pregbalin or gabapentin therapy. |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of medicine, Zagazig university | Zagazig | Elsharqya |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Balaban F, Yagar S, Özgök A, Koç M, Güllapoglu H. A randomized, placebo-controlled study of pregabalin for postoperative pain intensity after laparoscopic cholecystectomy. J Clin Anesth. 2012 May;24(3):175-8. doi: 10.1016/j.jclinane.2011.06.027. Epub 2012 Mar 28. — View Citation
Dahl JB, Mathiesen O, Møiniche S. 'Protective premedication': an option with gabapentin and related drugs? A review of gabapentin and pregabalin in in the treatment of post-operative pain. Acta Anaesthesiol Scand. 2004 Oct;48(9):1130-6. Review. — View Citation
Guay DR. Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Am J Geriatr Pharmacother. 2005 Dec;3(4):274-87. Review. — View Citation
Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in Postoperative pain | will be assessed by visual analogue scale (VAS), On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain. | at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively | |
Secondary | The level of sedation | using the modified Ramsay Sedation Score:
Patient is anxious and agitated or restless, or both. Patient is cooperative, oriented and tranquil. Patient responds to commands only. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. Patient exhibits sluggish response to light glabellar tap or loud auditory stimulus. Patient exhibits no response. |
at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively | |
Secondary | Total amount of rescue analgesic | Total amount of rescue analgesic requirement by the patient | in the first 24 hours |
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