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Compares treatment options for Post-operative Pain
Official title Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy
ClinicalTrials.gov ID: NCT05953766
What this study is testing
What is Ropivacaine injection?
Ropivacaine injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post-operative pain.
Also referred to as Naropin.
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
- The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 18 years of age or older
- Undergoing total laparoscopic hysterectomy
You likely can't join if
- Previous presacral neurectomy
- Concurrent surgical procedure other than salpingectomy and/or oophorectomy
- Gynecological cancer beyond stage 1 disease
- BMI \> 50
- Chronic opioid consumption
- Fibromyalgia
See the full eligibility criteria
- 18 years of age or older
- Undergoing total laparoscopic hysterectomy
- Previous presacral neurectomy
- Concurrent surgical procedure other than salpingectomy and/or oophorectomy
- Gynecological cancer beyond stage 1 disease
- BMI \> 50
- Chronic opioid consumption
- Fibromyalgia
- Language barrier
- Inability to communicate and provide consent
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, 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.