Status:
COMPLETED
Effects of Tapentadol Versus Oxycodone After Hysterectomy.
Lead Sponsor:
Oslo University Hospital
Conditions:
Pain, Postoperative
Pain Uterus
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
Opioids remain the first-line drugs for the treatment of moderate to severe postoperative pain, but the use is limited by well-known side-effects, most of which are dose-dependent. The opioid oxycodo...
Detailed Description
Postoperative pain is a major cause of postoperative suffering, prolonged hospitalization, complications and increased costs. It has been shown that postoperative pain is a frequent and unresolved pro...
Eligibility Criteria
Inclusion
- Women diagnosed with a benign gynecological condition, undergoing laparoscopic, supra-cervical or total hysterectomy in general anesthesia.
- Age 18-64 years.
- ASA (American Society of Anesthesiologists) classification I-III.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonisation GCP, and national/local regulations.
- The patients will be recruited from the patient population at the Department of Gynaecology.
Exclusion
- Age under 18 or over 65.
- BMI \> 31 and/or weight \<55 kg, \>85 kg.
- Chronic pain syndromes related to organ systems other than the female reproductive system.
- Chronic opioid therapy (codeine medication allowed up to 60 mg/day) or enteral steroid therapy.
- Alcohol or medical abuse/addiction.
- Chronic obstructive pulmonary disease (spirometry with postbronchodilator FEV1/FVC ratio less than 0.7), untreated asthma (FEV1/FVC is reduced to less than 0.70), obstructive sleep apnea or other conditions known to predispose for respiratory depression.
- Neurological diagnosis with affection of respiratory system or prone to seizures.
- Previously diagnosed kidney (glomerular filtration rate \<60 mL/min/1.73 m2 over 3 months) or liver impairment (ALAT \> 45 U/L; ASAT \> 35 U/L; ALP \> 105 U/L; GT \> 45 U/L age 18-39 or GT \> 75 U/L age over 39; LD \> 205 U/L).
- Biliary tract disease.
- Paralytic ileus.
- Heart failure (NYHA III-IV).
- Malignancy of any kind under treatment. Malignancy during last 5 years.
- HIV infection. Infections of any kind affecting the patient's clinical status, i.e. upper or lower airway infection, urinary tract infection, deep wound infection. Infections not affecting the patient's clinical status, i.e. conjunctivitis, is not an exclusion criteria.
- Untreated depression, severe anxiety or other psychiatric disorders independent of treatment.
- Nursing mothers.
- Cognitive failure, language barriers, hearing/visual disability or other factors which make follow-up difficult.
- Allergy or contraindication to any of the medications used in the study.
- Lactose intolerance.
- Monoamine oxidase inhibitors or SNRI (serotonin norepinephrine reuptake inhibitors) within 14 days prior to randomization. SSRI (selective serotonin reuptake inhibitors) use is not an exclusion criterion if stable dose for at least 30 days before screening.
- H1-antihistamine is not an exclusion criterion unless the patient experiences somnolence as a side-effect.
- The concurrent use of benzodiazepines, barbiturates, neuroleptics, phenytoin tricyclic antidepressants, gabapentinoids, tramadol, clonidine, cimetidine, rifampicin, protease inhibitors, St John's wort (Hypericum perforatum), macrolides and antimycotics such as ketoconazole and fluconazole is not allowed.
- Known complications to anesthesia or difficult airway (Definition of difficult airway: "The clinical situation in which a conventionally trained anesthesiologist experiences difficulty with mask ventilation, difficulty with tracheal intubation, or both.").
- Patients who have participated in other clinical trials during the last 6 months are excluded to avoid confounders to the current study and for patient safety reasons.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03314792
Start Date
December 4 2017
End Date
February 28 2019
Last Update
April 4 2019
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424