Marcaine for Pain After Ovarian Cyst Removal

Overseen By John O. Schorge, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Tennessee

Disqualifiers: Under 18, Hysterectomy, Septicemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Marcaine for pain relief after ovarian cyst removal?

Research shows that Marcaine, when used without epinephrine, effectively reduces the need for additional pain medication after surgeries, such as foot surgery and caesarean sections, indicating its potential to manage pain after ovarian cyst removal. ^{1 2 3 4 5}

Is Marcaine generally safe for use in humans?

Marcaine (bupivacaine) is generally considered safe when used correctly, with minimal side effects reported in various medical procedures, including obstetrics and oral surgery. It has a favorable balance between effectiveness and toxicity, especially when doses are carefully managed. ^{1 2 3 5 6}

How does the drug Marcaine differ from other treatments for pain after ovarian cyst removal?

Marcaine is unique because it provides effective pain relief with minimal side effects and is often used in combination with other agents like steroids to enhance its effect. It is known for its long-lasting pain relief, which can reduce the need for additional pain medication after surgery. ^{1 2 3 4 6}

What is the purpose of this trial?

We hypothesize that instilling intraperitoneal Marcaine (without epinephrine) at the end of a non-total laparoscopic gynecologic surgery (adnexa only, which includes the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue) will result in less pain and reduced opioid use postoperatively.

Eligibility Criteria

This trial is for individuals undergoing laparoscopic surgery for ovarian cyst removal. Participants should not be involved in any other studies that could affect pain perception or medication use.

Inclusion Criteria

BMI 55.0 or less

I am scheduled for a day surgery on my ovaries or fallopian tubes.

Exclusion Criteria

I have an irregular heartbeat.

Known hypersensitivity to bupivacaine or to any other local anesthetic agent

I have a blood infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic gynecologic surgery with either Marcaine or saline intraperitoneal wash

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and opioid use post-surgery

1 week

1 visit (in-person or via telephone)

Treatment Details

Interventions

• Marcaine hydrochloride without epinephrine 0.5%

Trial Overview The study tests if washing the surgical area with Marcaine, a local anesthetic, instead of normal saline reduces post-surgery pain and opioid need. It's a comparison to see which solution is more effective at managing pain after gynecologic surgery.

Participant Groups

Group I: Normal saline intraperitoneal wash post procedure Active Control 1 Intervention

The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline.

Group II: Marcaine hydrochloride without epinephrine 0.5% intraperitoneal wash Active Control 1 Intervention

The experimental group (comparison treatment) will receive an intraperitoneal wash with 20 mL of Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% at the end of surgery.

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Findings from Research

The study evaluates the effectiveness and benefits of using Marcaine 0.25% combined with Epinephrine 1:200,000 as a supplementary pain relief method during rhinoseptoplasty in children.

This analysis focuses on pediatric patients, highlighting the potential for improved pain management and reduced need for additional analgesics during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined anaesthesia for rhinoseptoplasty in pediatric patients]. Mayorov, VM., Akolzina, IL., Batueva, VA., et al.[2013]

Bupivacaine hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.

It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. Babst, CR., Gilling, BN.[2018]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Control of postoperative pain in foot surgery using a combination of anesthetic and steroid for local infiltration. [2013]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Combined anaesthesia for rhinoseptoplasty in pediatric patients]. [2013]

3. India pubmed.ncbi.nlm.nih.gov

Preventive Effects of Pre- and Intra-operative Marcaine, Lidocaine, and Marcaine Plus Lidocaine on Pain Relief in Lumbar Disc Herination Open Surgery. [2022]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Ilioinguinal nerve blockade with or without epinephrine for analgesia after caesarean section]. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. [2018]

6. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]