A Study of SABER-Bupivacaine in Patients Undergoing Hysterectomy

• Research type

  Research Study

• Full 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

• Sponsor organisation

  Nycomed

• Eudract number

  2007-006121-26

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  This trial is an international, multi-centre study to assess the effectiveness and safety of an investigational drug, SABER-Bupivacaine, for postoperative pain control in patients undergoing abdominal hysterectomy. Approximately 200 patients will be in the trial from centres across Europe.Following an initial screening period of up to 7 days, patients will be randomised (chosen by chance, like the flip of a coin) to receive either the study drug, standard bupivacaine treatment, or placebo (a dummy drug that looks like the study drug but contains no active ingredients) for a period of 14 days after their day of surgery. All patients will also be offered Morphine as needed plus paracetamol for post-operative pain treatment.During the study the patients will undergo the following study procedures: physical examination, vital signs recorded, ECGs performed, and blood samples taken for laboratory safety tests and pharmacokinetic analysis. Patients will also be required to complete an eDiary daily for pain assessment, assessment of opioid related side effects, and recording of any medication taken. The healing of the patient's surgical will also be evaluated regularly.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/16

• Date of REC Opinion

  23 Apr 2009

• REC opinion

  Further Information Favourable Opinion