Presacral Nerve Block for Postoperative Pain

Overseen By Shakiba Ardestani, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mount Sinai Hospital, Canada

Must not be taking: Opioids

Disqualifiers: Gynecological cancer, Fibromyalgia, 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: 4

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a presacral nerve block with ropivacaine, a local anesthetic, can reduce pain after a total laparoscopic hysterectomy. Participants will receive either the ropivacaine treatment or a placebo (a sham block with saline) to compare effects on pain relief. Women scheduled for a total laparoscopic hysterectomy who have not undergone presacral nerve surgery may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in pain management.

Do I need to stop taking my current medications for the trial?

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.

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

Research has shown that ropivacaine is generally safe for people and effectively manages post-surgical pain. Studies on its use for various nerve blocks have found it both safe and effective. One study found that ropivacaine, when used in the body cavity, helps with post-surgical pain and maintains a good safety profile.

While side effects can occur, they are usually mild, such as numbness or tingling at the injection site. Ropivacaine's established use in medical settings further assures its safety. Prospective clinical trial participants should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the presacral nerve block using ropivacaine because it offers a targeted approach to managing postoperative pain. Unlike standard treatments like opioids or non-steroidal anti-inflammatory drugs (NSAIDs), which can have systemic side effects, this method delivers pain relief directly to the presacral space. By using ropivacaine, a long-acting local anesthetic, the treatment potentially offers prolonged pain relief while minimizing the risk of side effects associated with systemic pain medications. This localized approach could improve recovery times and patient comfort following surgery.

What evidence suggests that this treatment might be an effective treatment for postoperative pain?

In this trial, participants will receive either a presacral nerve block with ropivacaine or a sham block. Research has shown that ropivacaine effectively manages post-surgical pain through nerve blocks. Studies have found that nerve blocks can significantly reduce the need for opioids, which are strong painkillers with many side effects. Specifically, a presacral nerve block with ropivacaine has eased pain after a laparoscopic hysterectomy, a surgery to remove the uterus. Patients who received ropivacaine reported less moderate to severe pain compared to those without the nerve block. Overall, using ropivacaine in a nerve block can make recovery more comfortable by reducing pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals scheduled to undergo a total laparoscopic hysterectomy. It's designed to see if a presacral nerve block can help manage post-operative pain.

Inclusion Criteria

I am scheduled for a total laparoscopic hysterectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total laparoscopic hysterectomy with either presacral nerve block or sham block

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Post-operative pain scores assessed at 1, 2, and 3 hours after surgery in the PACU

3 hours

Continuous monitoring

Follow-up

Participants are monitored for post-operative pain, opioid consumption, and adverse events

1 week

3 follow-up contacts (virtual) on post-operative days 1, 2, and 7

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine

Trial Overview The study compares two groups: one receiving a presacral nerve block with ropivacaine, and the other getting a sham block with saline. The goal is to assess pain management effectiveness after surgery.

How Is the Trial Designed?

Group I: Presacral Nerve Block Experimental Treatment 1 Intervention

Presacral nerve block using 20mL of local ropivacaine 5.0mg/ml instilled in the presacral space

Group II: Sham Block Placebo Group 1 Intervention

20mL of normal saline (sham block) instilled in the presacral space

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05953766

Study Details | NCT05953766 | Presacral Nerve Block ... A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456737/

Nerve Blocks for Post-Surgical Pain Management: A Narrative ... Nerve blocks show great promise as effective alternatives for managing post-surgical pain. They can reduce the need for opioids and their side effects.

3. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-01626443&doi=10.1002/central/CN-01626443&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

The Effect of Pre-sacral Nerve Block on Immediate Post ... The Effect of Pre-sacral Nerve Block on Immediate Post-operative Pain Following Laparoscopic Hysterectomy. NCT03646006.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11236761/

The impact of combined administration of ropivacaine ... The primary outcome was the incidence of moderate to severe pain at the first postoperative dressing change. Secondary outcomes included Quality ...

5. withpower.com withpower.com/trial/phase-2-pain-postoperative-6-2023-865bb

Presacral Nerve Block for Postoperative Pain This Phase 2 medical study run by Mount Sinai Hospital, Canada is evaluating whether Ropivacaine will have tolerable side effects & efficacy for patients ...

6. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1366070/full

The impact of combined administration of ropivacaine and ... The primary outcome was the incidence of moderate to severe pain at the first postoperative dressing change. Secondary outcomes included Quality ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11398749/

Efficacy and safety of intraperitoneal ropivacaine in pain ... Intraperitoneal infusion of ropivacaine has shown promising results in pain management post-surgery. Several studies have explored the efficacy and safety of ...