Erector Spinae Block for Post-Operative Pain in Breast Cancer Surgery

Overseen By Didem Bozak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Women's College Hospital

Must not be taking: Chronic opioids, Amide anesthetics

Disqualifiers: Cardiac, Respiratory, Neurological, Psychiatric, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to manage post-surgery pain for breast cancer patients using the Erector Spinae Block, a type of regional anesthesia. The goal is to determine if this method provides better pain relief and faster recovery compared to a placebo (inactive treatment). The researchers aim to help patients avoid heavy use of painkillers like opioids, which can cause side effects such as nausea. This trial may suit individuals undergoing day surgery for breast cancer, without a history of major heart or lung issues, or previous breast surgery on the same side. As an unphased trial, it offers a unique opportunity to contribute to research that could improve post-surgery recovery for future patients.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are using chronic opioids (30 mg or more of oxycodone per day), you would not be eligible to participate.

What prior data suggests that the Erector Spinae Block is safe for post-operative pain management in breast cancer surgery?

Research shows that the erector spinae plane block (ESPB) is generally safe for breast cancer surgery. Studies have found that ESPB can greatly reduce pain and the need for strong painkillers after surgery, leading to fewer side effects like nausea and a quicker recovery.

ESPB uses ultrasound to guide a needle, ensuring the correct placement of the numbing medicine. Patients usually tolerate this technique well. Existing studies for breast surgery have not reported any major safety concerns. However, more research is needed to fully understand its benefits and any possible risks. Overall, ESPB appears to be a promising and safe option for managing pain in breast cancer surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Erector Spinae Block (ESP) for managing post-operative pain in breast cancer surgery because it offers a targeted pain relief approach. Unlike traditional systemic pain medications that affect the entire body, the ESP block delivers a local anesthetic directly to the nerves near the spine, potentially reducing pain more effectively and with fewer side effects. This technique uses a precise ultrasound-guided injection, offering a novel, minimally invasive method that could improve patient comfort and recovery time compared to standard pain management methods.

What evidence suggests that the Erector Spinae Block is effective for post-operative pain in breast cancer surgery?

Research has shown that the erector spinae block (ESPB), which participants in this trial may receive, reduces pain after breast surgery. Studies have found that patients who received ESPB experienced less pain and required fewer painkillers like opioids. This reduction in opioid use is important because it can lead to fewer side effects, such as nausea and vomiting. One study found that ESPB was as effective as other pain management methods for breast cancer surgery. Overall, ESPB is considered a promising way to manage pain after surgery for these patients. Participants in the control group of this trial will receive a placebo block to compare the effectiveness of ESPB. ^{2 4 6 7 8}

Who Is on the Research Team?

Richard Brull, MD

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

This trial is for breast cancer surgery patients with an ASA classification of I-III and a BMI under 35. It's suitable for those having day surgery without severe respiratory or cardiac conditions, no history of significant chest surgeries (except lumpectomy), and not on high-dose opioids. Participants mustn't have allergies to local anaesthetics, be pregnant/nursing, or unable to consent.

Inclusion Criteria

You are in good to moderate health according to the ASA classification.

My surgery is scheduled as a day procedure.

You weigh less than 231 pounds (105 kilograms) for someone who is 5 feet 7 inches (170 centimeters) tall.

Exclusion Criteria

I am allergic to certain local anesthetics used for numbing.

I do not have severe heart conditions or irregular heartbeats.

I am allergic to a drug used in pain management protocols.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an ESP block or a sham block during ambulatory breast cancer surgery

1 day

1 visit (in-person)

Immediate Postoperative Recovery

Participants are monitored for quality of recovery and acute postoperative pain within 24 hours post-surgery

24 hours

Follow-up

Participants are monitored for postoperative pain, opioid consumption, and block-related complications

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Block
• Placebo Block

Trial Overview The study tests the effectiveness of erector spinae plane block versus a placebo in managing post-operative pain after breast cancer surgery. The goal is to see if this technique can improve recovery by reducing opioid use and side effects like nausea while promoting earlier discharge.

How Is the Trial Designed?

Group I: Erector spinae plane (ESP) block group Experimental Treatment 1 Intervention

Local anaesthetic infiltration utilising 1% lidocaine will occur, and an 80mm 22G block needle will be inserted using an in-plane cranial to caudad approach, the needle will be advanced to target the interfascial plane deep to the erector spinae muscle at the T2 transverse process. Once the needle tip is in the correct position, 20 ml of the local anaesthetic (ropivacaine 0.5% with 1:400,000 epinephrine) will be administered slowly in 5 ml aliquots under frequent aspiration and correct spread in the interfascial plane will be observed.

Group II: Control Group Placebo Group 1 Intervention

Patients randomised to the Control group will then receive a sham subcutaneous injection of 0.5ml normal saline injected at the same site as the ESP block (see above) under ultrasound guidance to stimulate a real block procedure.

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Published Research Related to This Trial

The erector spinae plane block (ESPB) significantly reduces total morphine consumption and improves pain control compared to general anesthesia in women undergoing modified radical mastectomy, with patients using only 4.9 mg of morphine on average versus 16.4 mg in the control group.

ESPB provides effective postoperative analgesia similar to the paravertebral block (PVB), with both techniques resulting in lower pain scores and longer times to first required anesthesia compared to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between erector spinae plane block and paravertebral block regarding postoperative analgesic consumption following breast surgery: a randomized controlled study. Elewa, AM., Faisal, M., Sjöberg, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8168047/

Analgesic effects of erector spinae plane block for patients ... ESPB significantly alleviated pain and reduced opioid consumption after breast surgery. Further research is needed to expand its clinical application.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07134933

The Effects of Erector Spinae Plane Block on Pain Scores ... We will investigate the effectiveness of ESP for managing acute pain after breast cancer surgery. Patients will randomise to receive either ...

3. gazimedj.com gazimedj.com/articles/evaluation-of-postoperative-pain-in-patients-undergoing-erector-spinae-plane-block-in-breast-surgeries/gmj.2024.4225

Evaluation of Postoperative Pain in Patients Undergoing ... In this study, we evaluated the analgesic efficacy of erector spinae plane block (ESPB) in patients undergoing breast surgery. Methods. Our ...

4. jag.journalagent.com jag.journalagent.com/agri/pdfs/AGRI-00087-EXPERIMENTAL_AND_CLINICAL_STUDIES-CIFTCI.pdf

Comparison of postoperative analgesic efficacy between ... Erector spinae plane block (ESPB) and rhomboid intercostal block (RIB) are effective analgesic techniques, and they are preferable because ...

5. esmoopen.com esmoopen.com/article/S2059-7029(25)00603-9/fulltext

180P Erector spinae plane block versus paraverbral block This study aims to compare the efficacy of ESP and PVB in postoperative pain control, patient satisfaction, and opioid consumption in breast cancer surgery.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39695870/

Analgesic efficacy and safety of erector spinae plane block ... While pain scores with either block are comparable, ESPB reduces postoperative morphine consumption and may be the favorable option in breast cancer patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05494502

Impact of Erector Spinae Plane Block on Chronic ... Erector spinae plane block (ESPB) provided excellent perioperative analgesia in patients undergoing breast surgery. Dexmedetomidine as an adjuvant of local ...

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01277-x

Analgesic efficacy and safety of erector spinae plane block in ... Ultrasound-guided ESPB is an effective approach for reducing morphine consumption and pain intensity within the first 24 h after breast cancer surgery, ...