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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Marcaine, a numbing medicine, can reduce pain and the need for opioids after surgery to remove ovarian cysts. Researchers will compare the effects of Marcaine to a standard saline wash used during surgery. The study seeks participants undergoing planned laparoscopic surgery involving the ovaries or nearby structures. Participants should not have a body mass index (BMI) over 55 and should not be undergoing a hysterectomy (removal of the uterus). As a Phase 4 trial, Marcaine is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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 is the safety track record for Marcaine hydrochloride without epinephrine?

Research has shown that Marcaine, also known as bupivacaine, is generally safe for people. Studies have found that it can significantly reduce pain in the abdomen after surgery compared to a placebo, a harmless substance given to some patients in experiments. No major differences in pain levels or the need for extra pain medicine were observed, suggesting it is well-tolerated. Marcaine without epinephrine is already used for pain control in other approved medical settings, indicating its safety. While side effects are possible, existing research supports its safe use in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard pain management options for post-surgery recovery, which typically involve oral or intravenous painkillers, the Marcaine hydrochloride intraperitoneal wash offers a unique delivery method right at the surgical site. This approach targets pain more directly and could potentially reduce the need for systemic pain medications like opioids, which come with a risk of side effects and dependency. Researchers are excited about this treatment because it could offer a more localized and efficient way to manage pain after ovarian cyst removal, potentially improving patient comfort and recovery times.

What evidence suggests that Marcaine might be an effective treatment for pain after ovarian cyst removal?

This trial will compare the use of Marcaine, also known as bupivacaine, with a saline solution for pain management after ovarian cyst removal surgery. Research has shown that Marcaine effectively reduces post-surgical pain. A review of studies found that administering bupivacaine inside the abdominal area significantly lowered pain levels at 6 and 24 hours after surgery compared to a placebo. Specifically, another study found that patients who received bupivacaine experienced less pain after laparoscopic surgery to remove an ovarian cyst. These findings suggest that Marcaine could help reduce pain and may also decrease the need for opioids after ovarian cyst removal surgery. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. ejgo.org ejgo.org/src/2024-ASGO/0254.pdf

Retrospective study on postoperative pain control using ... ... pain control to reduce the surgical burden on patients. Local anesthetics such as bupivacaine have been proven effective. Various methods, including ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8421670/

A Systematic Review and Meta-Analysis of Intraperitoneal ... We conclude that intraperitoneal bupivacaine significantly reduced the VAS score for pain compared with that of the placebo at 6 and 24 hours.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465015001703

Postoperative Analgesia after Laparoscopic Ovarian Cyst ... Postoperative analgesia after laparoscopic ovarian cyst resention was minimal after intraperitoneal or peritoneal instillation of ropivacaine [912]. Epidural ...

4. journals.lww.com journals.lww.com/gmit/fulltext/2022/11040/comparative_study_of_postoperative_analgesic.8.aspx

Comparative Study of Postoperative Analgesic Effects of... The LA group showed a significantly higher postoperative NRS pain score at 1 h after surgery compared to the TAP group for overall surgeries (2.1 ± 1.3 vs. 1.7 ...

5. researchgate.net researchgate.net/publication/397300298_Efficacy_of_intraperitoneal_bupivacaine_hydrocortisone_and_magnesium_sulfate_in_different_combinations_for_pain_relief_after_laparoscopic_ovarian_cystectomy_a_double-blind_randomized_controlled_trial

Efficacy of intraperitoneal bupivacaine, hydrocortisone, and ... In addition, group II had statistically significant lower abdominal static and dynamic pain scores than group III in the most of assessment points (p <0.05).