Ketorolac + Lidocaine for Pain Relief During Hysteroscopy

Overseen By Virginia H Flatow, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Narcotics, NSAIDs

Disqualifiers: Thrombocytopenia, Gastritis, Renal disease, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Single visit

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding ketorolac to lidocaine can better relieve pain during office hysteroscopies. Hysteroscopies, procedures to examine the inside of the uterus, can be uncomfortable. The trial will compare two groups: one using lidocaine with ketorolac (a nonsteroidal anti-inflammatory drug) and the other using only lidocaine. It seeks participants assigned female at birth who are scheduled for a hysteroscopy at Mount Sinai Hospital. Individuals with allergies to the medications or certain health conditions, such as kidney disease, are not eligible. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to explore new pain relief options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of long-term narcotic use, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using ketorolac and lidocaine together for pain relief is generally well-tolerated. Studies have found that combining 30 mg of ketorolac with lidocaine provides better pain relief than using lidocaine alone for up to 24 hours, making the combination effective in reducing pain.

Regarding safety, this treatment is in the early stages of testing, so there is limited information about its safety in humans. However, both ketorolac and lidocaine are well-known medications. Lidocaine is often used to numb areas, and ketorolac is a common pain reliever. Both have been used safely in various medical situations.

Early studies mainly focus on the effectiveness of this combination for pain, while also closely monitoring any side effects. So far, no major safety concerns have been reported. However, since this is early testing, participants help researchers gather more information on both its effectiveness and safety.

Prospective trial participants should discuss any concerns with the study team, who can provide more detailed information tailored to individual health needs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for pain relief during hysteroscopy typically involve the use of local anesthetics like lidocaine alone. However, combining ketorolac with lidocaine offers a unique approach. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that can enhance pain relief by targeting inflammation in addition to numbing the area. This combination could potentially provide more effective and longer-lasting pain relief compared to lidocaine by itself, which excites researchers about its potential benefits for patients undergoing hysteroscopy.

What evidence suggests that the combined ketorolac and lidocaine paracervical block might be an effective treatment for pain relief during hysteroscopy?

Research has shown that a mix of ketorolac and lidocaine can greatly reduce pain during procedures like hysteroscopy. In this trial, one group of participants will receive a paracervical block with both ketorolac and lidocaine, while another group will receive a block with just lidocaine. Specifically, one study found that this combination lessened pain during the widening of the cervix, a step in many gynecological procedures. Ketorolac is a pain reliever, while lidocaine is a numbing medicine. Together, they offer better pain relief than lidocaine alone, potentially making hysteroscopy more comfortable for patients. ^{3 4 6 7 8}

Who Is on the Research Team?

Charles Ascher-Walsh, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals experiencing abnormal uterine bleeding who are undergoing office hysteroscopy, a procedure to look inside the uterus. Participants should meet certain health criteria not specified here.

Inclusion Criteria

I am female by birth and scheduled for a hysteroscopy at Mount Sinai Hospital.

Exclusion Criteria

Contraindications to lidocaine

I have a long-term liver condition.

Allergy to lidocaine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standard lidocaine paracervical block or a lidocaine plus ketorolac paracervical block during office hysteroscopy

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for pain, patient satisfaction, and adverse events immediately after the procedure and 30 minutes post-procedure

30 minutes

1 visit (in-person)

Long-term follow-up

Participants are followed for the duration of the two-year study period to assess long-term outcomes and adverse events

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Combined Ketorolac and Lidocaine Paracervical Block

Trial Overview The study compares pain relief during hysteroscopy using two methods: one combines ketorolac (a pain reliever) with lidocaine (an anesthetic), and the other uses just lidocaine. It's a randomized trial, so participants are put into groups by chance.

How Is the Trial Designed?

Group I: Lidocaine plus ketorolac Experimental Treatment 3 Interventions

Paracervical block will be performed with lidocaine plus ketorolac

Group II: Lidocaine alone Placebo Group 2 Interventions

Paracervical block will be performed with just lidocaine

Combined Ketorolac and Lidocaine Paracervical Block is already approved in United States, European Union for the following indications:

Approved in United States as Ketorolac and Lidocaine Combination for:

• Pain management during office hysteroscopies
• Pain management during first-trimester surgical abortions

Approved in European Union as Ketorolac and Lidocaine Combination for:

• Local anesthesia for minor surgical procedures
• Pain management during gynecologic procedures

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study of 129 patients undergoing diagnostic office hysteroscopy, oral diclofenac potassium significantly reduced pain perception compared to both hyoscine-N-butyl bromide (HBB) and placebo, with lower pain scores reported during and after the procedure.

Diclofenac not only resulted in less pain but also led to a shorter procedure duration and fewer adverse effects compared to HBB, which had a higher incidence of dizziness among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Diclofenac Potassium Versus Hyoscine-N-Butyl Bromide in Reducing Pain Perception during Office Hysteroscopy: ARandomized Double-blind Placebo-controlled Trial. Abbas, AM., Elzargha, AM., Ahmed, AGM., et al.[2019]

In a study of 120 patients undergoing hysterosalpingography, the combination of intramuscular dexketoprofen and a paracervical block provided the best pain relief during the procedure and 30 minutes afterward.

Adding a paracervical block to either systemic or local analgesics did not show any additional benefits, highlighting that the most effective pain management strategy involved the combination of dexketoprofen and the block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the addition of a paracervical block to systemic or local analgesics improve the pain perceived by the patient during hysterosalpingography? Hacivelioglu, S., Gencer, M., Cakir Gungor, A., et al.[2013]

In a study of 50 women undergoing first-trimester surgical abortions, a paracervical block using combined ketorolac and lidocaine significantly reduced perceived pain during cervical dilation compared to a lidocaine-only block, with pain scores of 59.8 mm versus 74.8 mm.

Despite the reduction in pain during cervical dilation, there was no significant difference in overall satisfaction with pain control or perceived pain during the procedure and postoperative pain between the two groups, suggesting that while the combination may help with specific pain points, overall satisfaction remains similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Cansino, C., Edelman, A., Burke, A., et al.[2021]

A study comparing two local analgesia methods for outpatient hysteroscopy found no significant difference in pain relief between a paracervical block and a uterosacral block, indicating both methods are equally effective.

The uterosacral block, which uses less lignocaine and takes less time, offers a more efficient and cost-effective option for pain management during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient hysteroscopy: a comparison of 2 methods of local analgesia. Finikiotis, G., Tsocanos, S.[2019]

In a study of 84 women undergoing outpatient hysteroscopy, combined local and paracervical anesthesia resulted in significantly less pain during the procedure compared to local intracervical anesthesia, with mean pain scores of 2.1 vs 3.2 on a scale of 0 to 10.

Patients reported mild pain overall, but those receiving combined anesthesia also experienced lower pain levels at 10 and 30 minutes post-procedure, indicating that this method may enhance patient comfort during and shortly after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy. Al-Sunaidi, M., Tulandi, T.[2013]

In a study of 70 women undergoing diagnostic hysteroscopy, rectal diclofenac was found to be more effective than intrauterine lidocaine in reducing pain during the insertion and removal of the hysteroscope.

However, both methods showed similar effectiveness during the actual visualization of the uterine cavity, indicating that while diclofenac may provide better overall pain relief, both options are viable for managing discomfort during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Transcervical Intrauterine Lidocaine Instillation with Rectal Diclofenac for Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial. Mohammadi, SS., Abdi, M., Movafegh, A.[2020]

Citations

1. withpower.com withpower.com/trial/phase-1-uterine-hemorrhage-10-2024-b92ec

Ketorolac + Lidocaine for Pain Relief During Hysteroscopy A study comparing two local analgesia methods for outpatient hysteroscopy found no significant difference in pain relief between a paracervical block and a ...

2. mountsinai.org mountsinai.org/clinical-trials/combined-ketorolac-lidocaine-paracervical-block-for-office-hysteroscopy

Combined Ketorolac and Lidocaine Paracervical Block for ... Summary: A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard ...

3. trial.medpath.com trial.medpath.com/clinical-trial/bfa6dfedb6ad6fac/ketorolac-lidocaine-hysteroscopy-trial

Combined Ketorolac and Lidocaine Paracervical Block for ... Primary Objective: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19935022/

Paracervical block with combined ketorolac and lidocaine ... Conclusion: Paracervical block with combined ketorolac and lidocaine significantly decreases perceived pain associated with cervical dilation during first- ...

5. scholars.mssm.edu scholars.mssm.edu/en/clippings/combined-ketorolac-and-lidocaine-paracervical-block-for-office-hy

Combined Ketorolac and Lidocaine Paracervical Block for ... Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial. Charles Ascher-Walsh · Obstetrics ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7899906/

Ketorolac plus Lidocaine vs Lidocaine for pain relief ... Local injection of 30 mg Ketorolac in combination with Lidocaine resulted in improved pain control compared to Lidocaine alone for up to 24 ...

7. journals.lww.com journals.lww.com/md-journal/fulltext/2021/02190/ketorolac_plus_lidocaine_vs_lidocaine_for_pain.52.aspx

Ketorolac plus Lidocaine vs Lidocaine for pain relief... Local injection of 30 mg Ketorolac in combination with Lidocaine resulted in improved pain control compared to Lidocaine alone for up to 24 ...

8. societyfp.org societyfp.org/awarded_grants/sfp1-1/

Paracervical block with combined ketorolac and lidocaine ... This randomized clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ...