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Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy

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ClinicalTrials.gov Identifier: NCT02936934
Recruitment Status : Unknown
Verified October 2016 by VIRGINIA ALEYDA SANCHEZ LOPEZ, Hospital Civil de Guadalajara.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
VIRGINIA ALEYDA SANCHEZ LOPEZ, Hospital Civil de Guadalajara

Brief Summary:
The objective of this study is compare adverse reactions associated with oxycodone and morphine for the treatment of postoperative pain after abdominal hysterectomy

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Morphine Drug: Oxycodone Phase 4

Detailed Description:

A randomized single-blind study, was performed to compare the adverse reactions associated with oxycodone and morphine in patients undergoing abdominal hysterectomy.

process:

  1. A clinical history of patients candidates to participate in the study will be developed.
  2. If you meet the selection criteria will be held the invitation to participate in the study, reading the letter under information

Patients who agree to participate in the study will be managet during the surgical procedure:

15 mg mixed blockade with bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg intravenously during surgery metamizol 3) After the surgical procedure (immediate postoperative)

• the patient to group A or B (randomization) is assigned, masking infusions and allocation will be conducted by an outside person who will test an additional record the names of the patients and the drug administered.

A bolus of oxycodone or morphine 10% calculated dose for intravenous infusion 0.075mg intravenous palonosetron prophylaxis of emesis Detection and assessment of severity of adverse drug reactions will be conducted by an interview that will be at 0,1,2,6,12 and 24 hours after the onset of analgesia. Instrument designed for the detection of RAM will be used and classify its severity according to common terminology criteria for adverse events (CTCAE). Futhermore, measuring systemic blood pressure, heart rate, oxygen saturation will be performed through the use of Nihon Kohden monitor (model BSN-2301K). Pain assessment will be made by the numerical scale (NRS). The researcher responsible for the detection and assessment of adverse reactions to opioids and others determinations, remain mowed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Morphine
Multimodal analgesia to morphine
Drug: Morphine

Interventions pre-specified to be administered to participants:

Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery

Intravenous infusion:

200μg / kg of morphine + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration:24hours


Experimental: Oxycodone
Multimodal analgesia to oxycodone
Drug: Oxycodone

Interventions pre-specified to be administered to participants:

Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery

Intravenous infusion:

150μg / kg of oxycodone + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration: 24hours.





Primary Outcome Measures :
  1. Adverse drug reactions (questionnaire) [ Time Frame: 24 hours ]
    Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis


Secondary Outcome Measures :
  1. Postoperative pain (Numeric Pain Rating Scale) [ Time Frame: 24 hours ]
  2. systemic blood pressure (mmHg) (physiological parameter) [ Time Frame: 24 hours ]
    Monitor Nihon Kohden BSM-2301K

  3. Heart rate (physiological parameter) [ Time Frame: 24 hours ]
    Monitor Nihon Kohden BSM-2301K

  4. Oxygen saturation (physiological parameter) [ Time Frame: 24 hours ]
    Monitor Nihon Kohden BSM-2301K



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients scheduled for abdominal hysterectomy
  • Signing for informed consent

Exclusion Criteria:

  • Patients used with MAO inhibitor drugs (<14 days before surgery)
  • History of substance abuse
  • Hypersensitivity to opioids and others drugs of multimodal analgesia (metamizol and lidocaine)
  • Pretreatment of any opioid (<7/2 lives of the drug in question)
  • Chronic pain of any etiology (> 6 months)
  • Diagnosis of bowel obstruction
  • Renal or hepatic insufficiency
  • Asthma, chronic obstructive pulmonary disease (COPD), and/ or hypothyroidism.
  • Patients requiring general anesthesia for surgical complications

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): NCT02936934


Contacts
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Contact: VIRGINIA A SANCHEZ, MD 3319837964 aleyda_sanmis7@hotmail.com

Sponsors and Collaborators
Hospital Civil de Guadalajara

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Responsible Party: VIRGINIA ALEYDA SANCHEZ LOPEZ, MD Pharmacology, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT02936934     History of Changes
Other Study ID Numbers: HospitalCG
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VIRGINIA ALEYDA SANCHEZ LOPEZ, Hospital Civil de Guadalajara:
Adverse Drug Reaction
Morphine
Oxycodone
Abdominal hysterectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents