To investigate the efficacy and safety of the CollaRx Bupivacaine Implant in women following abdominal hysterectomy or other nonlaparoscopic benign gynecological procedure MedDRA version: 9.1 Level: LLT Classification code 10044080 Term: Total abdominal hysterectomy
Conditions
Interventions
Product Name: CollaRx Bupivacaine Implant
Pharmaceutical Form: Medicated sponge
INN or Proposed INN: Bupivacaine
CAS Number: 14252-80-3
Other descriptive name: Bupivacaine hydrochloride
Concentration
Sponsors
Innocoll Technologies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for entry into the study, patients must meet all of the following inclusion criteria prior to surgery: 1. Must be a woman who is at least 18 but not more than 75 years of age. 2. Have a body mass index (BMI) > 19 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to amide local anesthetics, opioids, bovine products or to inactive ingredients of the test article. 2. Presence of clinically significant cardiac arrhythmias or atrioventricular (AV) conduction disorders. Cardiac arrhythmias or atrioventricular (AV) conduction disorders that are abnormal, but the investigator considers them not to be clinically significant with respect to the study, require prior medical monitor approval. 3. Concomitant use of other amide local anesthetics. 4. Concomitant use of antiarrhythmics (eg, amiodarone). 5. Concomitant use of propranolol. 6. Concomitant use of strong/moderate CYP3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice). 7. Has used aspirin or aspirin-containing products within 7 days of surgery. Aspirin at a dose of Q 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for R 30 days prior to Screening. 8. Previous major surgery in the last 3 months. 9. Requires any additional surgical procedures either related or unrelated to the abdominal hysterectomy during the same hospitalization (except for the specific allowed procedures noted in above Inclusion Criteria). 10. Received neuraxial (spinal or epidural) opioid analgesics either prior to or during the abdominal hysterectomy. 11. Received local anesthetic infiltration of the surgical wound prior to, during or immediately after closure. 12. Is scheduled to receive postoperative local anesthetics via an indwelling catheter (either neuraxial or regional). 13. Patient underwent additional procedures during surgery, such as lysis of many adhesions, which in the opinion of the Investigator increased the visceral pain. 14. Has known or suspected history of alcohol or drug abuse or misuse within the previous 3 years or evidence for tolerance or physical dependency on opioids analgesics or sedative-hypnotic medications. 15. Uses opioids or tramadol daily for > 7 days prior to test article administration. Patients who, in the Investigator’s opinion, are developing opioid tolerance are to be excluded. 16. Has impaired liver function, aspartate aminotransferase (AST)/alanine transaminase (ALT)/bilirubin R 3.0 times the upper limit of normal (ULN), active hepatic disease, evidence of clinically significant liver disease or other condition (eg, alcoholism, cirrhosis or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with exposure to test article. 17. Presence of any clinically significant unstable cardiac, neurological, immunological, renal or hematological disease or any other condition that in the opinion of the Investigator could compromise the patient’s welfare, ability to communicate with the study staff or otherwise contraindicate study participation. 18. Patient is judged by the investigator to be at risk for infection or slow wound healing. 19. Patient has a chronic painful condition that might confound the assessment of pain associated with the abdominal hysterectomy. 20. Has taken pain medication (including nonsteroidal anti-inflammatory drugs [NSAIDs]) that, in the opinion of the Investigator, would be expected to confound the analgesic responses the day of surgery. 21. Has been treated within 2 weeks of surgery with agents that could affect the analgesic response (such as central alpha agents [clonidine and tizanidine], neuroleptic agents and other anti-psychotic agents). 22. Has been treated with monoamine oxid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the narcotic-sparing effect of the CollaRx Bupivacaine Implant (bupivacaine sponge) with the placebo sponge for the treatment of pain in the abdominal hysterectomy wound for the first 24 hours after surgery.;Secondary Objective: To compare the narcotic-sparing effect of the bupivacaine sponge with the placebo sponge for the treatment of pain in the abdominal hysterectomy wound over 48 and 72 hours after surgery. To evaluate the analgesic effect of the bupivacaine sponge compared with placebo sponge for the treatment of pain in the abdominal hysterectomy wound. To assess the safety and tolerability of the bupivacaine sponge when implanted into abdominal hysterectomy wounds during open surgery.;Primary end point(s): Efficacy parameters of bupivacaine • Total use of opioid rescue analgesia over 0 to 24 hours • Total use of opioid rescue analgesia over 0 to 48 hours • Total use of opioid rescue analgesia over 0 to 72 hours • Pain intensity rating on the VAS • Pain intensity rating on a 4-point Likert scale • Time to first use of opioid rescue analgesia Safety parameters • Treatment-emergent AEs • Vital signs - heart rate, respiration rate, systolic and diastolic blood pressure and body temperature | — |
Countries
United Kingdom
Outcome results
None listed