Clinical trial NCT00993226: An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Official title: 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 Undergoing Primary, Elective, Open, Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Postoperative pain
Local anaesthesia
Postoperative pain after open abdominal hysterectomy surgery
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
First posted: 2009-10-12
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.


Eligibility criteria: Inclusion Criteria:

* A planned elective, abdominal hysterectomy
* Patients suitable for general anaesthesia

Exclusion Criteria:

* Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
* 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)
* Abnormal ECG
* Prolonged QT syndrome
* Current or regular use of analgesic medication for other indication(s)

Primary outcomes:
measure: Pain Intensity (PI)
timeFrame: 1 to 72 hours post-surgery
measure: Supplemental Opioid Use
timeFrame: 0-3 days after surgery
Secondary outcomes:
measure: Time to First Opioid Rescue Medication Usage
timeFrame: 0-14 days after surgery
measure: Opioid Related Side Effects
timeFrame: 0-7 days after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Nycomed
city: Bayreuth
country: Germany
facility: Nycomed
city: Dresden
country: Germany
facility: Nycomed
city: Budapest
country: Hungary
facility: Nycomed
city: Békéscsaba
country: Hungary
facility: Nycomed
city: Debrecen
country: Hungary
facility: Nycomed
city: Györ
country: Hungary
facility: Nycomed
city: Nyíregyháza
country: Hungary
facility: Nycomed
city: Szolnok
country: Hungary
facility: Nycomed
city: Székesfehérvár
country: Hungary
facility: Nycomed
city: Tatabánya
country: Hungary
facility: Nycomed
city: Riga
country: Latvia
facility: Nycomed
city: Stockholm
country: Sweden
facility: Nycomed
city: London
country: United Kingdom
facility: Nycomed
Study officials:
affiliation: Headquarters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References: