Pain, Postoperative Clinical Trial
Official title:
Preemptive Analgesia With Amitryptyline for Prevention of Post-operative Pain in Women After Total Abdominal Hysterectomy: a Randomized Clinical Trial
NCT number | NCT03587025 |
Other study ID # | IMIP |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 1, 2015 |
Est. completion date | October 30, 2018 |
Verified date | November 2018 |
Source | University of Campinas, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether amitryptyline is effective in the prevention of pain in women after a total abdominal hysterectomy.
Status | Completed |
Enrollment | 150 |
Est. completion date | October 30, 2018 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Women scheduled for total abdominal hysterectomy for benign conditions (e.g. hemorrhagic and / or uterine fibroid disorder); - Age between 18 and 60; Exclusion Criteria: - Endometriosis; - Abnormal cervicovaginal smears; - Uterine prolapse; - Patients with a history of intolerance to opioids or narcotics; - Patients with contraindications to the use of amitriptyline (e.g., ischemic heart disease, glaucoma) - addicted to alcohol or drugs; - Use of analgesics in the 24 hours prior to the possible administration of amitriptyline; - Failure to provide informed consent; - Different anesthesia from spinal anesthesia |
Country | Name | City | State |
---|---|---|---|
Brazil | FCM CG - Faculdade de Ciências Médicas de Campina Grande | Campina Grande | Paraíba |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Ajori L, Nazari L, Mazloomfard MM, Amiri Z. Effects of gabapentin on postoperative pain, nausea and vomiting after abdominal hysterectomy: a double blind randomized clinical trial. Arch Gynecol Obstet. 2012 Mar;285(3):677-82. doi: 10.1007/s00404-011-2023- — View Citation
Arsenault A, Sawynok J. Perisurgical amitriptyline produces a preventive effect on afferent hypersensitivity following spared nerve injury. Pain. 2009 Dec;146(3):308-14. doi: 10.1016/j.pain.2009.08.003. Epub 2009 Sep 11. — View Citation
Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374. Review. — View Citation
Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12. — View Citation
Clarke-Pearson DL, Geller EJ. Complications of hysterectomy. Obstet Gynecol. 2013 Mar;121(3):654-73. doi: 10.1097/AOG.0b013e3182841594. Review. — View Citation
Goodwin SA. A review of preemptive analgesia. J Perianesth Nurs. 1998 Apr;13(2):109-14. Review. — View Citation
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation
Møiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology. 2002 Mar;96(3):725-41. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twenty-four hours after surgery | The postoperative pain will be measured twenty-four hours after surgery, using the visual pain scale (0 - no pain to 10 - very hard pain) | Twenty-four hours after surgery | |
Secondary | Intensity of acute postoperative pain six hours after the procedure | It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain) | Six hours after the procedure | |
Secondary | Intensity of acute postoperative pain twelve hours after the procedure | It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain) | Twelve hours after the procedure | |
Secondary | Intensity of acute postoperative pain twenty-four hours after the procedure | It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain) | Twenty-four hours after the procedure | |
Secondary | Intensity of acute postoperative pain forty-eight hours after the procedure | It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain) | forty-eight hours after the procedure | |
Secondary | Records of rescue analgesia | Use of rescue analgesia with the infusion of morphine - It will be checked using the patient records at the hospital | From the end of the procedure until 48 hours after that | |
Secondary | Compare surgical time (duration, in minutes) and frequency of intraoperative and postoperative complications | Relationship between surgical time (duration) and complications occurrence | From the end of the procedure until sixty days after that. | |
Secondary | Frequency of adverse effects | Onset of adverse effects like migraine, sickness, numbness, vomiting, itching, etc | From the end of the procedure until 48 hours after that | |
Secondary | Length of hospitalization | Time between admission and releasing, in hours | participants will be followed for the duration of hospital saty, an expected average of 48 hours. | |
Secondary | Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, six hours after surgery | The postoperative pain will be measured after six hours after surgery, using the visual pain scale (0 - no pain to 10 - very hard pain) | Six hours after surgery. | |
Secondary | Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twelve hours after surgery | The postoperative pain will be measured after six hours after surgery, using the visual pain scale (0 - no pain to 10 - very hard pain) | Twelve hours after surgery | |
Secondary | Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, forty-eight hours after surgery | The postoperative pain will be measured forty-eight hours after surgery, using the visual pain scale (0 - no pain to 10 - very hard pain) | Forty-eight hours after surgery |
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