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PCA and pump with saline infusion for up to five days for Laparoscopic Surgery

Phase 2
Waitlist Available
Led By Margherita Cadeddu, MD
Research Sponsored by Margherita CADDEDU
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op 1, 2, 3, 5 and 14
Awards & highlights

Study Summary

The incisions used in abdominal surgery can be quite painful, requiring strong pain medications. A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery. The main research question is whether use of the pain pump will result in decreased hospital length of stay. The research is important because if the pain pump is found to be effective, it can substantially decrease the length of stay. Areas to be studied include hospital length of stay, patient's comfort post-operatively, and post-operative complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op and post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op and post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
length of stay postoperative in hospital
Secondary outcome measures
amount of narcotic and non-narcotic analgesia required
incidence of in-hospital and post-discharge complications
subjective pain of patient

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: PCA and pump with saline infusion for up to five daysExperimental Treatment1 Intervention
Group II: PCA and bupivicaine infusion for up to five daysExperimental Treatment1 Intervention
Group III: patient controlled analgesia (PCA) onlyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bupivicaine
2009
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Margherita CADDEDULead Sponsor
McMaster UniversityOTHER
880 Previous Clinical Trials
2,597,768 Total Patients Enrolled
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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