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

NCT02828059 | Withdrawn

• 1 other identifier: ZKSJ0095
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain

Keywords

Caesarean section

Outcome Measures

Primary Outcomes (1)

• Maximal perceived pain intensity 24 h after surgery

  Subjectively rated pain perception by a 10-point-numeric rating scale

  24 hours

Secondary Outcomes (10)

• Perceived pain at rest over 12 h after surgery

  12 hours

• Perceived pain at mobilization over 12 h after surgery

  12 hours

• Perceived pain at rest over 24 h after surgery

  24 hours

• Perceived pain at mobilization over 24 h after surgery

  24 hours

• Perceived pain at rest over 48 h after surgery

  48 hours

Other Outcomes (1)

• Adverse events and adverse drug reactions

  48 hours

Interventions

Ropivacaine DRUG

Surgical wound Infiltration over 48 hours

Also known as: ReadyFusor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing delivery by elective or emergent Caesarean section

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ekkehard Schleussner, MD

  Department of Obstetrics, Jena University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share