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New treatment option for Acute Post Operative Pain
Official title PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose
ClinicalTrials.gov ID: NCT05534945
What this study is testing
What is Programmed intermittent epidural bolus 5 ml?
Programmed intermittent epidural bolus 5 ml is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute post operative pain.
Also referred to as 5 mL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 18-85 years old
- ASA I to III
You likely can't join if
- Contraindication to TEA: Coagulopathy, sepsis or local infection at the epidural insertion site, patient refusal
- Inability to site the epidural catheter
- Inability to use PCEA/Communication barrier
- Daily opioid use
- Planned postoperative admission to the intensive care unit
- Patient refusal
See the full eligibility criteria
- 18-85 years old
- ASA I to III
- Contraindication to TEA: Coagulopathy, sepsis or local infection at the epidural insertion site, patient refusal
- Inability to site the epidural catheter
- Inability to use PCEA/Communication barrier
- Daily opioid use
- Planned postoperative admission to the intensive care unit
- Patient refusal
- Predefined criteria for exclusion after inclusion: Failure to obtain a sensory block to ice in the Post Anesthesia Care Unit (PACU)(see Methods), Reoperation within 1 postoperative day
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.