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Pre-sacral nerve block for Postoperative Pain

Phase 4
Waitlist Available
Led By Mara Sobel, MD
Research Sponsored by Mount Sinai Hospital, Canada
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 on day of surgery
Awards & highlights

Study Summary

Hysterectomy (removal of the uterus) is the most common major gynecologic surgery performed in Canada. With a focus on minimally invasive techniques and optimization of peri-operative pain control, gynaecologists have made great strides towards reducing hospital stay and accelerating post-operative recovery. These are essential achievements, both for patients and their families and for our resource-limited public healthcare system. Optimization of peri-operative pain control is multifactorial and includes, for example, administration of pre-operative analgesics, infiltration of incision sites with local anesthetic and provision of post-operative pain medications. As the understanding of pain mechanisms evolves, the incorporation of intra-operative nerve blocks has become yet another effective strategy to reduce post-operative pain. The presacral nerve plexus, which carries nerve fibers from the uterus to the brain, is an important pathway that transmits midline pelvic pain in women. Destruction of the pre-sacral nerves has been shown to provide excellent pain control in a variety of clinical settings. While transection of the presacral nerve at the time of surgery is technically challenging, instilling a presacral nerve block is surprisingly straightforward making this technique safe to perform in the hands of many gynecologists. In this technique, local anesthetic is instilled into the presacral space using a needle inserted through the abdomen. Given that the presacral nerve plexus is an integral pain pathway for the uterus, the investigators hypothesize that the addition of a presacral nerve block during laparoscopic (camera surgery) hysterectomy would confer an additional reduction in immediate post-operative pain. The proposed study therefore aims to look at the impact of presacral nerve block versus a sham (blank) block on immediate post-operative pain in a group of women scheduled to undergo laparoscopic hysterectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative pain at 3 hours
Secondary outcome measures
Adverse Events
Post-operative anti-emetic consumption
Post-operative narcotic consumption
+2 more
Other outcome measures
Estimated blood loss
Operative Time
Time to discharge
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pre-sacral nerve blockExperimental Treatment1 Intervention
10 mL bupivacaine (5mg/mL)
Group II: Sham blockPlacebo Group1 Intervention
10 mL normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,548 Total Patients Enrolled
Mara Sobel, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
1 Previous Clinical Trials
41 Total Patients Enrolled

Frequently Asked Questions

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~9 spots leftby Apr 2025