An international, randomised, double blinded, multi-centre, active- and placebo-controlled dose response trial to evaluate the efficacy and safety of SABER-Bupivacaine for postoperative pain control in patients following arthroscopic shoulder surgery
- Conditions
- Postoperative pain control in patients undergoing elective arthroscopic shoulder surgery.MedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative pain
- Registration Number
- EUCTR2007-006122-96-DE
- Lead Sponsor
- ycomed Danmark ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
1. Written informed consent obtained according to local regulations before any trial-related activities. A trial-related activity is any procedure that would not have been performed during the routine management of the patient
2. Subacromial impingement syndrome, diagnosed by a positive subacromial impingement test, full passive range of motion and exclusion of shoulder instability
3. MRI with intact rotator cuff as judged by radiologist
4. Age 18 years of age and above
5. Patients suitable for general anaesthesia
6. Willing to refrain from strenuous activities and avoid modifications to prescribed
physiotherapy/exercise levels throughout the course of the trial
7. Ability to read, understand, communicate and voluntarily sign the approved informed consent form before any trial specific procedures
For female patients of childbearing potential
8. A negative urine pregnancy test at screening
9. Use of adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device) throughout the trial period and for 1 week after the trial is completed, according to local law
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Participation in another clinical trial with an investigational drug or device within 30 days before inclusion in this trial
2. Previous participation in this trial
3. Known serious / important reactions in previous anaesthesia procedures with local
anaesthestics
4. Known major joint trauma, infection, avascular necrosis, chronic dislocation,
inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
5. Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
6. Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances.
History of cured localised malignancies is allowed (i.e. basal or squamous cell skin
carcinoma, breast carcinoma or cervical carcinoma).
7. Abnormal ECG (interpretation of ECG must be done by physician). Abnormalities such as sinus tachycardia, right bundle branch block, ectopic atrial rhythm or premature atriel contractions are not necessarily reason for exclusion (interpretation by physician).
8. Prolonged QT syndrome (QT greater than 450msec for males, greater than 470msec for females) or family history of long QT syndrome (interpretation of ECG must done be by physician)
9. Current or regular use of analgesic medication for other indication(s)
10. Conditions contraindicated for use of opioids, including paralytic ileus, acute or severe bronchial asthma or hypercarbia
11. Current or regular use of anticonvulsants or antiepileptics
12. Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed
connective tissue disease)
13. Current or regular use of antidepressants, monoamine oxidase inhibitors, or medication known to be associated with QT prolongation
14. Known or suspected alcohol abuse or illicit drug use within the 6 months prior to trial enrolment
15. Known sensitivity to bupivacaine (or similar local anaesthetics), benzyl alcohol or other trial drugs (paracetamol, morphine) or their constituents
16. Unwillingness or inability to comply with the trial visit schedule
17. Breastfeeding
18. Situated in an institution due to regulatory order or judicial direction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control administered into the subacromial space in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations.;Secondary Objective: No secondary objective;Primary end point(s): Two primary efficacy variables will be used in this trial:<br>• Pain intensity (PI) area under the curve (AUC) on movement over the period 1 to 72<br>hours post surgery using a 10 point Numerical Rating Scale (NRS) for PI recording<br>(Standardised movement at pain assessment). For the purpose of<br>interpretation, the AUC will be normalised by dividing with the time interval over<br>which it is computed<br>• Total use of opioid rescue analgesia 0 to 72 hours after surgery
- Secondary Outcome Measures
Name Time Method