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Opioid Analgesic
Continuous Wound Infusion (Intervention Group) for Anesthesia (CIVIMEC Trial)
N/A
Waitlist Available
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
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 in postanesthesia care unit (pacu), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery
Awards & highlights
CIVIMEC Trial Summary
This trial compares pain relief methods for c-section recovery, using a score to measure quality of recovery at 24 hrs.
Eligible Conditions
- Quality of Recovery
- Anesthesia
- Postoperative Pain
- Cesarean Section
CIVIMEC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ in postanesthesia care unit (pacu), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in postanesthesia care unit (pacu), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ObsQoR-11 at 24 hours
Secondary outcome measures
Global health score
Nausea and vomiting score
ObsQoR-11 at 48 and 72 hours
+5 moreCIVIMEC Trial Design
2Treatment groups
Active Control
Group I: Continuous Wound Infusion (Intervention Group)Active Control1 Intervention
Spinal anesthesia without intrathecal morphine and postoperative continuous wound infusion with ropivacaine.
Group II: Intrathecal Morphine (Control Group)Active Control1 Intervention
Spinal anesthesia with intrathecal morphine and postoperative continuous wound infusion with sterile saline.
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Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,560 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been taking opioids regularly for a long time.You suffer from long-term pain.You are carrying more than one baby.You cannot participate if you are planning to have a cesarean delivery that is not medically necessary.You have a heart condition.You have very severe obesity with a body mass index (BMI) of over 40.You are unable to communicate or understand instructions because of language barriers or physical/mental limitations.I'm sorry, but the criterion "Emergency CD" is not clear to me. Can you please provide more context or information?The baby is born too early (before 37 weeks of pregnancy) or has abnormalities.You cannot have spinal anesthesia.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Wound Infusion (Intervention Group)
- Group 2: Intrathecal Morphine (Control Group)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to participate in this clinical experiment at the moment?
"The information available on clinicaltrials.gov suggests that this medical trial is not actively recruiting any more subjects; the study was first posted in February of 2023, and last edited a month later. Nevertheless, there are 622 alternative clinical trials accepting patients presently."
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