Pain after laparoscopic hysterectomy. MedDRA version: 19.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Palexia® 50 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Tapentadol
CAS Number: 175591-09-0
Other descriptive name: T
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women, age 18-64 years, diagnosed with a benign gynecological condition, undergoing laparoscopic, supra-cervical or total hysterectomy in general anesthesia. Informed consent. ASA classification I-III. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: BMI > 31 and/or weight 85 kg. Chronic pain syndromes related to other organ systems than the female reproductive tract 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, untreated asthma, obstructive sleep apnea or other conditions known to predispose for respiratory depression. Neurological diagnosis with affection of respiratory system or prone to seizures. Kidney or liver impairment. Biliary tract disease. Paralytic ileus. Heart failure (NYHA III-IV). Malignancy. HIV infection or other active infection. Untreated depression, severe anxiety or other psychiatric disorders independent of treatment. 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. Benzodiazepines, barbiturates, neuroleptics, phenytoin tricyclic antidepressants, gabapentanoids, tramadol, clonidine, cimetidine, rifampicin, protease inhibitors, St John’s wort (Hypericum perforatum), macrolides and antimycotics such as ketoconazole and fluconazole. Known complications to anesthesia or difficult airway. Requiring sedative medication in the postoperative observational period. Patients who has participated in other clinical trials during the last 6 months is excluded to avoid confounders to the current study and for patient safety reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of our study is to examine the analgesic effects in patients receiving either tapentadol or oxycodone during the first postoperative day after hysterectomy.;Secondary Objective: As a secondary goal we want to examine the respiratory depressive effect from tapentadol compared to oxycodone. ;Primary end point(s): Pain at rest, measured by the patient scoring a value on the numerical rating scale for pain (values 0 - 10 where 0 is no pain and 10 is worst possible pain), registered 1 hour postoperatively. ;Timepoint(s) of evaluation of this end point: 1 hour postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30, 60, 120, 180 minutes and 24 hours postoperatively.; Secondary end point(s): Pain at rest and while coughing, measured with the numerical rating scale for pain (NRS), registered at 30 minutes, 2, 3 and 24 hours postoperatively. Pain intensity difference (PID) at rest at 30 minutes, 1, 2, 3 and 24 hours will be calculated from these values. Sum of pain intensity difference (SPID) at 24 hours is calculated as the time-weighted sum of the PID scores (SPID t = SPID x (time t - time t-1)). Pain relief, measured with categorical scale “none, slight, moderate, good or complete”, at 30 minutes, 1, 2, 3 and 24 hours postoperatively. Total pain relief (TOTPAR) over 24 hours will be calculated from these values. Worst pain during 24 hours is measured with NRS. Global medication performance (GMP) after 24 hours: “poor, fair, good, very good, excellent”. Time to first rescue medicine (IV and/or PO) and total rescue analgesic consumption IV and PO over 24 hours is also registered. Measurement of end-tidal carbon dioxide, data are collected at 30, 60, 120, 180 minutes postoperatively. Any episodes of ETCO2 > 7.0 or respiratory rate < 10 are also recorded. Respiratory rate at rest is measured at 30, 60, 120, 180 minutes and 24 hours postoperatively. | — |
Countries
Norway
Contacts
Public ContactDept. of Anesthesiology, Ullevaal
Oslo University Hospital
Outcome results
None listed