What side effects are associated with this type of intervention?

Common treatments for acute pain using local anesthetic injections, such as those similar to the Midpoint Transverse Process to Pleura (MTP) Block, can have side effects including localized pain at the injection site, temporary numbness or weakness, and rare cases of systemic toxicity with symptoms like dizziness, tinnitus, metallic taste, seizures, or cardiac arrhythmias. There are also risks of infection or bleeding at the injection site.

What prior FDA approvals exist?

The FDA has approved several local anesthetics, including bupivacaine, lidocaine, and ropivacaine, for the treatment of acute pain through various nerve block techniques. These drugs are commonly used in procedures like epidural and paravertebral blocks to inhibit pain signal transmission by blocking sodium channels. These methods are similar to the Midpoint Transverse Process to Pleura (MTP) Block, which also aims to manage pain by locally anesthetizing specific nerves.

What other types of research exist?

Promising novel alternatives to the Midpoint Transverse Process to Pleura (MTP) Block for acute pain management include: 1) Thoracolumbar Interfascial Plane (TLIP) Block, which has both classical (cTLIP) and modified (mTLIP) techniques and has shown effective analgesia after lumbar spinal surgery. 2) Continuous Femoral Nerve Block, which provides prolonged pain relief and has been effective in postoperative settings such as total knee arthroplasty. 3) Adductor Canal Block, which offers effective analgesia with less impact on motor function, making it suitable for lower limb surgeries. These techniques are supported by recent studies and are expected to be viable options in 2024.

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MTP Block vs Paravertebral Block for Pain Relief in Breast Cancer Surgery

N/A

Waitlist Available

Led By Ioana Costache, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Summary

This trial will compare a new pain relief method called MTP block to traditional methods for patients undergoing breast surgery. The MTP block aims to provide safer and easier nerve numbing to reduce pain.

Who is the study for?

This trial is for English or French-speaking individuals scheduled for major breast surgery, with a BMI under 30 and an ASA physical status of I-III. It's not suitable for those who've had previous breast surgery on the same side, have nerve issues in the chest, can't have regional anesthesia, refuse this type of pain control, use opioids regularly, suffer from chronic pain disorders or cannot consent.

What is being tested?

The study is testing how well a new pain-blocking procedure called MTP block works compared to no intervention (control) and another established method known as thoracic paravertebral block (PVB). Participants will be randomly assigned to one of these three groups during their breast cancer surgery.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the injection site, potential nerve damage or infection from the blocks used in both MTP and PVB procedures. The control group would not experience these since they do not receive these interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative analgesia during the first 24 hours.

Secondary study objectives

Post-operative quality of recovery during the first 24 hours.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MTP block groupExperimental Treatment1 Intervention

MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Group II: PVB groupActive Control1 Intervention

paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

Group III: control groupPlacebo Group1 Intervention

local anesthetic infiltration subcutaneous 1% lidocaine

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Local anesthetics, such as those used in the Midpoint Transverse Process to Pleura (MTP) Block, work by blocking sodium channels in nerve cells, preventing the initiation and transmission of pain signals to the brain. This targeted approach is crucial for acute pain patients as it provides effective pain relief at the site of injury or surgery, minimizing the need for systemic pain medications and their associated side effects. Regional anesthesia techniques, including nerve blocks, utilize this mechanism to offer significant pain control during and after surgical procedures.

Feeling the Heat: Evolutionary and Microbial Basis for the Analgesic Mechanisms of Photobiomodulation Therapy.Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

574 Previous Clinical Trials

3,094,541 Total Patients Enrolled

3 Trials studying Acute Pain

1,972 Patients Enrolled for Acute Pain

Ioana Costache, MDPrincipal InvestigatorOttawa Hospital, Ottawa Hospital Research Institute

Media Library

Control Group Clinical Trial Eligibility Overview. Trial Name: NCT03713255 — N/A

Acute Pain Research Study Groups: PVB group, MTP block group, control group

Acute Pain Clinical Trial 2023: Control Group Highlights & Side Effects. Trial Name: NCT03713255 — N/A

Control Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03713255 — N/A

~26 spots leftby Oct 2025

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