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

Sponsor

Hospital Civil de Guadalajara (Other)

Overall Status

Unknown status

CT.gov ID

NCT02936934

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Feb 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adverse drug reactions (questionnaire) [24 hours]
Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis

Secondary Outcome Measures

Postoperative pain (Numeric Pain Rating Scale) [24 hours]
systemic blood pressure (mmHg) (physiological parameter) [24 hours]
Monitor Nihon Kohden BSM-2301K
Heart rate (physiological parameter) [24 hours]
Monitor Nihon Kohden BSM-2301K
Oxygen saturation (physiological parameter) [24 hours]
Monitor Nihon Kohden BSM-2301K

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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