Continuous Wound Infiltration for Diminution of Post-surgery Pain After Caesarean Section

• Status: Withdrawn
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

A medical approach that warrants continuous and reliable local administration of non-opioid analgesic drugs might substantially improve post-surgery pain management in CS, while decreasing the necessity of staff-dependent invasive procedures and the probability of untoward effects following systemic drug exposure. ReadyfusOR® is a formulation comprising a Ropivacain-loaded single-use pump which has been approved for regional application of the analgesic drug, also comprising obstetric interventions. There is, however, scarce scientific information on the efficacy and benefit of this anesthetic drug formulation for pain management following CS by means of continuous wound infiltration.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jena University Hospital
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Elective or emergent Caesarean section under spinal or general anesthesia

• Medically indicated necessity of post-surgery analgesia

• Signed informed consent

• Body Mass Index above 20 and below 35

Exclusion Criteria:

• Wound drainage application following surgery

• Epidural catheter following surgery

• Planned concurrent surgical Intervention

• Chronic high-dose opioid use (>20 mg oxycodone equivalent daily) over more than 4 weeks prior to surgery

• History of, suspected or present addiction or abuse of illicit drug(s), prescription medicine(s) or alcohol during the preceding 2 years

• Intolerance or allergy to any of the medications planned for use

• Concurrent painful physical conditions that may require analgesic Treatment

• Current or planned administration of Long-acting Opioids, selective Serotonin reuptake Inhibitors, gabapentin, pregabalin or duloxetine within 30 days preceding and7or following surgery

• Use of systemic glucocorticoids (except for induction of fetal lung maturation) within 1 month prior to enrollment

• Uncontrolled anxiety, schizophrenia or other psychiatric conditions which could interfere with the compliance and subjective assessment of Treatment effects (decision at the discretion of the investigator)

• Inability to operate devices for Patient-controlled analgesia