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Preemptive Analgesia With Amitryptyline for Prevention of Pain in Women After Hysterectomy

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ClinicalTrials.gov Identifier: NCT03587025
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Henriques de França Neto, University of Campinas, Brazil

Brief Summary:
The purpose of this study is to determine whether amitryptyline is effective in the prevention of pain in women after a total abdominal hysterectomy.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Amitriptyline Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preemptive Analgesia With Amitryptyline for Prevention of Post-operative Pain in Women After Total Abdominal Hysterectomy: a Randomized Clinical Trial
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Amitryptyline
Patients who will be take amitryptyline, 75mg, only use, 30min before surgery.
Drug: Amitriptyline
Amitriptyline compared with placebo for preemptive analgesia in women after abdominal hysterectomy.

Placebo Comparator: Placebo
Patients who will be take placebo 30min before surgery.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twenty-four hours after surgery [ Time Frame: 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)


Secondary Outcome Measures :
  1. Intensity of acute postoperative pain six hours after the procedure [ Time Frame: Six hours after the procedure ]
    It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain)

  2. Intensity of acute postoperative pain twelve hours after the procedure [ Time Frame: Twelve hours after the procedure ]
    It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain)

  3. Intensity of acute postoperative pain twenty-four hours after the procedure [ Time Frame: Twenty-four hours after the procedure ]
    It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain)

  4. Intensity of acute postoperative pain forty-eight hours after the procedure [ Time Frame: forty-eight hours after the procedure ]
    It will be measured using the visual pain scale (0 - no pain to 10 - very hard pain)

  5. Records of rescue analgesia [ Time Frame: From the end of the procedure until 48 hours after that ]
    Use of rescue analgesia with the infusion of morphine - It will be checked using the patient records at the hospital

  6. Compare surgical time (duration, in minutes) and frequency of intraoperative and postoperative complications [ Time Frame: From the end of the procedure until sixty days after that. ]
    Relationship between surgical time (duration) and complications occurrence

  7. Frequency of adverse effects [ Time Frame: From the end of the procedure until 48 hours after that ]
    Onset of adverse effects like migraine, sickness, numbness, vomiting, itching, etc

  8. Length of hospitalization [ Time Frame: participants will be followed for the duration of hospital saty, an expected average of 48 hours. ]
    Time between admission and releasing, in hours

  9. Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, six hours after surgery [ Time Frame: 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)

  10. Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twelve hours after surgery [ Time Frame: 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)

  11. Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, forty-eight hours after surgery [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587025


Locations
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Brazil
FCM CG - Faculdade de Ciências Médicas de Campina Grande
Campina Grande, Paraíba, Brazil, 58411-120
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Study Chair: Guilherme V Mascena, PhD FCM-CG

Publications of Results:
Other Publications:
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Responsible Party: Antonio Henriques de França Neto, Principal Investigator, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03587025     History of Changes
Other Study ID Numbers: IMIP
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Keywords provided by Antonio Henriques de França Neto, University of Campinas, Brazil:
amitryptyline
Analgesia
Hysterectomy
Pain, Postoperative
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants