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

• ClinicalTrials.gov Identifier: NCT02936934
• Recruitment Status: Unknown
• First Posted: October 18, 2016
• Last Update Posted: October 18, 2016
• Sponsor: Hospital Civil de Guadalajara
• Information provided by (Responsible Party): VIRGINIA ALEYDA SANCHEZ LOPEZ, Hospital Civil de Guadalajara

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:

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 Design

• 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

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Hospital Civil de Guadalajara

More Information

• 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
• 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:

Oxycodone; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents