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Local Anesthetic

Bupivacaine for Postoperative Pain After Hysterectomy

Phase 4
Waitlist Available
Research Sponsored by MediSys Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
Presence of malignancy
Must not have
Conversion to laparotomy
Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of treatment at 4 hours
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to find out if giving an injection of a numbing medication in the vaginal area before surgery can reduce the need for pain medication after the operation and make patients more comfortable and satisfied.

Who is the study for?
This trial is for individuals who have undergone a hysterectomy and are experiencing postoperative pain. Participants should not currently have infections or other conditions that could interfere with the study.
What is being tested?
The study aims to see if injecting Bupivacaine, a local anesthetic, into the vaginal cuff before closing it up after surgery can reduce the need for pain meds afterwards and improve comfort.
What are the potential side effects?
Bupivacaine may cause side effects like numbness around the injection area, weakness, dizziness, nausea or even more serious heart or nervous system issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and need a laparoscopic hysterectomy for a non-cancerous condition.
Select...
I have cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My surgery was changed to an open procedure.
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I am not allergic to Bupivacaine, epinephrine, tramadol, or oxycodone.
Select...
I have had several surgeries in my abdomen or pelvic area.
Select...
I use a lot of pain medication before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to end of treatment at 4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of treatment at 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Patient Change in Pain Score (0-10)

Side effects data

From 2009 Phase 4 trial • 180 Patients • NCT00527332
13%
Abdominal wound complication
8%
Infections
5%
Lower urinary tract infection
2%
Urinary bladder injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Anesthesia
General Anesthesia

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.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vaginal Cuff AnesthesiaExperimental Treatment1 Intervention
Group II: Vaginal Cuff SalinePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacain
2022
Completed Phase 4
~1640

Find a Location

Who is running the clinical trial?

MediSys Health NetworkLead Sponsor
3 Previous Clinical Trials
59 Total Patients Enrolled
~67 spots leftby Oct 2025
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