Ketorolac + Lidocaine for Pain Relief During Hysteroscopy

Overseen by Charles Ascher-Walsh, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Narcotics, NSAIDs

Disqualifiers: Thrombocytopenia, Gastritis, Renal disease, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.

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.

What data supports the effectiveness of the drug combination of Ketorolac and Lidocaine for pain relief during hysteroscopy?

Research on similar procedures, like first-trimester surgical abortion, shows that a paracervical block with combined ketorolac and lidocaine can help reduce perceived pain. Additionally, studies on other procedures suggest that combining local anesthesia with a paracervical block can improve pain relief. ^{1 2 3 4 5}

How does the drug Ketorolac + Lidocaine for pain relief during hysteroscopy differ from other treatments?

The combination of Ketorolac and Lidocaine in a paracervical block is unique because it combines a non-steroidal anti-inflammatory drug (NSAID) with a local anesthetic, potentially offering enhanced pain relief by addressing both inflammation and nerve pain directly at the cervix, unlike other methods that may use these components separately or rely on systemic administration. ^{1 2 3 4 6}

Research Team

Charles Ascher-Walsh, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Combined Ketorolac and Lidocaine Paracervical Block (Non-opioid Analgesic)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Findings from Research

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]

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]

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 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 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]

References

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

Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Outpatient hysteroscopy: a comparison of 2 methods of local analgesia. [2019]

3. Oman pubmed.ncbi.nlm.nih.gov

Comparing Transcervical Intrauterine Lidocaine Instillation with Rectal Diclofenac for Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial. [2020]

4. England 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? [2013]

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

A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy. [2013]

6. United States 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. [2019]