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Pre-sacral nerve block for Infections

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 3 hours post-operatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial tests if a pain relief method can reduce discomfort for women having uterus removal surgery using a camera. The goal is to see if this method helps manage pain better after surgery.

Eligible Conditions
  • Infections
  • Postoperative Pain

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

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
203 Previous Clinical Trials
69,376 Total Patients Enrolled
2 Trials studying Infections
577 Patients Enrolled for Infections
Mara Sobel, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
1 Previous Clinical Trials
41 Total Patients Enrolled
~8 spots leftby Nov 2025
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