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

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

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Morphine; Drug: Oxycodone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: VIRGINIA A SANCHEZ, MD; Phone Number: 3319837964; Email: aleyda_sanmis7@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug reactions (questionnaire)	Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain (Numeric Pain Rating Scale)		24 hours
systemic blood pressure (mmHg) (physiological parameter)	Monitor Nihon Kohden BSM-2301K	24 hours
Heart rate (physiological parameter)	Monitor Nihon Kohden BSM-2301K	24 hours
Oxygen saturation (physiological parameter)	Monitor Nihon Kohden BSM-2301K	24 hours

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Morphine; Adverse Drug Reaction; Oxycodone; Abdominal hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Oxycodone
• Other Study ID Numbers: HospitalCG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO