Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Morphine
Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Adverse Drug Reaction, Morphine, Oxycodone, Abdominal hysterectomy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Morphine
Oxycodone
Arm Description
Multimodal analgesia to morphine
Multimodal analgesia to oxycodone
Outcomes
Primary Outcome Measures
Adverse drug reactions (questionnaire)
Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis
Secondary Outcome Measures
Postoperative pain (Numeric Pain Rating Scale)
systemic blood pressure (mmHg) (physiological parameter)
Monitor Nihon Kohden BSM-2301K
Heart rate (physiological parameter)
Monitor Nihon Kohden BSM-2301K
Oxygen saturation (physiological parameter)
Monitor Nihon Kohden BSM-2301K
Full Information
NCT ID
NCT02936934
First Posted
October 14, 2016
Last Updated
October 14, 2016
Sponsor
Hospital Civil de Guadalajara
1. Study Identification
Unique Protocol Identification Number
NCT02936934
Brief Title
Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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:
A clinical history of patients candidates to participate in the study will be developed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Adverse Drug Reaction, Morphine, Oxycodone, Abdominal hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Multimodal analgesia to morphine
Arm Title
Oxycodone
Arm Type
Experimental
Arm Description
Multimodal analgesia to oxycodone
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
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 Measure Information:
Title
Adverse drug reactions (questionnaire)
Description
Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain (Numeric Pain Rating Scale)
Time Frame
24 hours
Title
systemic blood pressure (mmHg) (physiological parameter)
Description
Monitor Nihon Kohden BSM-2301K
Time Frame
24 hours
Title
Heart rate (physiological parameter)
Description
Monitor Nihon Kohden BSM-2301K
Time Frame
24 hours
Title
Oxygen saturation (physiological parameter)
Description
Monitor Nihon Kohden BSM-2301K
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VIRGINIA A SANCHEZ, MD
Phone
3319837964
Email
aleyda_sanmis7@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
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