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

NCT ID: NCT02936934

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-02-28

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:

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Morphine

Multimodal analgesia to morphine

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

Oxycodone

Multimodal analgesia to oxycodone

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Civil de Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

VIRGINIA ALEYDA SANCHEZ LOPEZ

MD Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

VIRGINIA A SANCHEZ, MD

Role: CONTACT

aleyda_sanmis7@hotmail.com

3319837964

Other Identifiers

HospitalCG

Identifier Type: -

Identifier Source: org_study_id