60 Participants Needed

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

DB
Overseen ByDidem Bozak

Trial Summary

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 data supports the effectiveness of the treatment Erector Spinae Block for post-operative pain in breast cancer surgery?

Research shows that the Erector Spinae Plane Block (ESPB) is effective for managing pain after breast cancer surgery, as it has been successfully used in various surgical procedures, including thoracic and abdominal surgeries, and improves recovery quality after mastectomy.12345

Is the Erector Spinae Block safe for humans?

The Erector Spinae Block (ESP Block) has been studied for its safety in breast cancer surgeries, and research indicates it is generally safe for use in humans for managing post-operative pain.12467

How does the erector spinae plane block treatment differ from other treatments for post-operative pain in breast cancer surgery?

The erector spinae plane block (ESPB) is a novel regional anesthesia technique that provides pain relief by blocking nerve signals in a specific area of the back, which can reduce the need for opioids and their associated side effects. Unlike traditional pain management methods, ESPB targets a wide range of nerve roots from T1 to L3, offering effective pain control for breast surgery patients.12348

What is the purpose of this trial?

Regional anaesthesia combined with general anaesthesia has become common in the perioperative management of breast cancer surgery patients. Regional techniques have been recognised to provide excellent post-operative analgesia. It enhances multi-modal analgesia regimes while being opioid sparing, reducing incidence of post-operative nausea and vomiting and allowing earlier mobilisation/discharge and improving treatment success. Therefore identifying the correct regional anaesthetic technique for this group of patients is important in providing optimum peri-operative care.

Research Team

Richard Brull, MD, FRCPC - Academics at ...

Richard Brull, MD

Principal Investigator

Women's College Hospital

Eligibility Criteria

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.
See 12 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Erector spinae plane (ESP) block groupExperimental Treatment1 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 GroupPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials
108
Recruited
43,700+

Findings from Research

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.
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]

References

Analgesic efficacy and safety of erector spinae plane block in breast cancer surgery: a systematic review and meta-analysis. [2022]
Efficacy and safety of erector spinae plane block for postoperative analgesia in breast cancer surgery-A systematic review and meta-analysis. [2023]
Multimodal analgesia with multiple intermittent doses of erector spinae plane block through a catheter after total mastectomy: a retrospective observational study. [2023]
Comparison between erector spinae plane block and paravertebral block regarding postoperative analgesic consumption following breast surgery: a randomized controlled study. [2022]
Efficacy of ultrasound-guided erector spinae plane block on postoperative quality of recovery and analgesia after modified radical mastectomy: randomized controlled trial. [2021]
Erector Spinae Plane Block Versus Serratus Plane Block in Breast Conserving Surgery: Α Randomized Controlled Trial. [2021]
Efficacy of ultrasound-guided erector spinae plane block following breast surgery - A double-blinded randomised, controlled study. [2022]
Erector Spinae Plane Block Decreases Pain and Opioid Consumption in Breast Surgery: Systematic Review. [2022]
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