A comparison of pain relief and effects on respiration from tapentadol and oxycodone after surgical removal of the uterus.

Phase 1

• Conditions: Pain after laparoscopic hysterectomy.; MedDRA version: 19.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-001285-23-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

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

BMI > 31 and/or weight <55 kg, >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.