Paravertebral Block for Postoperative Pain

Recruiting at 1 trial location

Overseen By Jean-Charles Hogue

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Axillary dissection, Severe hepatic insufficiency, Kidney failure, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage pain after a mastectomy, which involves breast removal surgery with immediate reconstruction. Researchers are comparing two pain management methods: a paravertebral block (a nerve-numbing shot given before surgery) and the usual painkillers administered after surgery. The goal is to determine which method more effectively reduces pain in the first few days following surgery. Women scheduled for one breast removal and reconstruction might be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to important research that could enhance post-surgical pain management for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on antiplatelet or anticoagulant therapy, you may need to stop them to meet anesthesia standards.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that paravertebral blocks (PVB) are generally safe for patients undergoing breast surgery. Studies indicate that PVB, whether used alone or with general anesthesia, controls pain more effectively after surgery and has few side effects. One study found that using PVB for breast surgery carries a very low risk of complications, confirming its safety for post-surgery pain management. These findings suggest that PVB is well-tolerated and effective for pain relief, making it a promising option for patients seeking to manage pain after a mastectomy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the paravertebral block for postoperative pain management because it offers a targeted approach to pain relief, unlike the usual systemic analgesics. Most standard treatments, like opioids and NSAIDs, work throughout the entire body and can have widespread side effects. In contrast, the paravertebral block delivers anesthesia directly to the nerves near the spine, potentially reducing pain more effectively and with fewer side effects. This precision in delivery could lead to better pain control and a quicker recovery for patients undergoing mastectomy.

What evidence suggests that the paravertebral block is effective for post-mastectomy pain?

Research shows that a paravertebral block (PVB) can effectively manage post-surgical pain. In studies involving chest surgery patients, PVB significantly reduced pain compared to other methods. It decreases the need for additional pain medication, potentially speeding up recovery. This trial will compare the effectiveness of a preoperative paravertebral block on the side of mastectomy, in addition to usual analgesia, with usual analgesia alone. Although the mechanisms of pain after a mastectomy are not fully understood, PVB's success in similar surgeries suggests it might also help manage pain after a mastectomy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for women aged 18-70 scheduled for unilateral mastectomy with immediate reconstruction. It aims to help those who may experience postoperative pain, specifically the chronic type known as PMPS that can occur after such surgeries.

Inclusion Criteria

I am a woman set for a one-sided breast removal and immediate reconstruction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total mastectomy with immediate reconstruction and receive either a paravertebral block or usual analgesia

1 week

1 visit (in-person)

Postoperative Monitoring

Evaluation of postoperative pain using the Brief Pain Inventory (BPI) at 24, 48, and 72 hours after surgery

72 hours

3 visits (in-person)

Follow-up

Participants are monitored for chronic pain at the surgical site at 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Paravertebral Block

Trial Overview The study compares two pain management methods: a Paravertebral block (BPV) and usual analgesia, to see which is better at controlling functional pain in the first three days after surgery under general anesthesia.

How Is the Trial Designed?

Group I: Paravertebral block Experimental Treatment 1 Intervention

Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia.

Group II: Usual analgesia Active Control 1 Intervention

Usual analgesia, as per anesthesiologist's preferences.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Published Research Related to This Trial

Ultrasound-guided bilateral thoracic paravertebral block is a safe and effective method for managing pain after cardiac surgery, showing similar pain control to thoracic epidural block, but with some advantages.

Patients receiving paravertebral block had shorter ICU stays and lower rates of urinary retention and vomiting compared to those with epidural analgesia, indicating potential benefits in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial. El Shora, HA., El Beleehy, AA., Abdelwahab, AA., et al.[2020]

Paravertebral blockade is a safe and effective method for managing acute surgical pain during and after surgery, allowing for either single injections or continuous administration of local anesthetics.

This technique is generally safer than epidural analgesia, especially for patients on anticoagulants, but there is still a risk of local anesthetic toxicity, and patients typically require additional pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic paravertebral block (PVB) analgesia. Cox, F., Cousins, A.[2018]

In a study of 380 women undergoing breast surgery, paravertebral block did not significantly reduce the incidence of chronic pain three months after surgery, with similar rates of chronic pain in both the paravertebral and control groups.

However, the paravertebral block did lead to significantly less immediate postoperative pain and a 73% reduction in morphine use compared to the control group, indicating its effectiveness in managing acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Paravertebral Block and Chronic Pain after Breast Cancer Surgery: A Double-blind Randomized Trial. Albi-Feldzer, A., Dureau, S., Ghimouz, A., et al.[2021]

Patients receiving a paravertebral block (PVB) in addition to general anesthesia (GA) experienced significantly lower pain scores at rest and during movement at multiple time points after breast surgery, indicating improved postoperative pain management.

The combination of PVB and GA not only reduced the incidence of postoperative nausea and vomiting but also resulted in higher quality of recovery scores and decreased need for additional analgesics, suggesting enhanced overall recovery for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect on improvement of recovery and pain scores of paravertebral block immediately before breast surgery. Li, NL., Yu, BL., Tseng, SC., et al.[2011]

A continuous infusion of ropivacaine via a thoracic paravertebral block significantly reduced pain scores at rest and during coughing in postoperative patients compared to a control group, indicating improved pain management.

Patients receiving the ropivacaine infusion experienced fewer side effects, such as nausea and urinary retention, while maintaining safe plasma levels of the drug, suggesting a safer alternative to traditional epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy. Marret, E., Bazelly, B., Taylor, G., et al.[2022]

In a study involving 42 patients undergoing laparotomy, adding dexmedetomidine to bupivacaine for paravertebral blocks significantly reduced pain scores and total analgesic consumption in the first 48 hours post-surgery.

The combination of dexmedetomidine and bupivacaine also extended the time to the first analgesic request, indicating improved pain management without increasing side effects or complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Dexmedetomidine to Bupivacaine in Ultrasound-guided Thoracic Paravertebral Block for Pain Management after Upper Abdominal Surgery: A Double-blind Randomized Controlled Trial. Alimian, M., Imani, F., Rahimzadeh, P., et al.[2022]

Thoracic paravertebral block (PVB) provides comparable postoperative pain relief to epidural block (EP) in patients who cannot receive EP, with similar pain scores measured on a numerical rating scale (NRS).

PVB has a better safety profile, as there were no adverse events reported in the PVB group, while approximately 10% of EP patients experienced complications such as hypotension and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thoracic Paravertebral Block in Patients Ineligible for Epidural Block]. Kojima, H., Isaka, M., Yasuura, Y., et al.[2017]

Paravertebral block provides superior pain control and better preservation of postoperative pulmonary function compared to intravenous analgesia, making it a preferred choice for thoracotomy patients.

When compared to thoracic epidural analgesia, paravertebral block shows similar effectiveness in pain management and pulmonary function, but has a better safety profile overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia for thoracic surgery: the role of paravertebral block. Piraccini, E., Pretto, EA., Corso, RM., et al.[2022]

In a clinical trial involving 70 patients who underwent thoracotomy, the paravertebral block (PVB) was found to be as effective as the epidural block (EP) for managing postoperative pain, with similar pain scores at rest measured at 2, 24, and 48 hours after surgery.

PVB demonstrated a favorable safety profile, with no significant differences in complications or the need for additional pain relief compared to EP, suggesting that PVB could be a simpler and safer alternative for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paravertebral block via the surgical field versus epidural block for patients undergoing thoracotomy: a randomized clinical trial. Kobayashi, R., Mori, S., Wakai, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600725/

Effectiveness of Surgeon-Performed Paravertebral Block ... Effectiveness of surgeon-performed paravertebral block analgesia for minimally invasive thoracic surgery: a randomized clinical trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11087611/

Is paravertebral block the new standard of care for ... Effective pain control is critical for quick recovery of patients undergoing video-assisted thoracoscopic surgery (VATS).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772993124000093

Efficacy of Methylene Blue Thoracic Paravertebral Block in ... Conclusions. PVB with methylene blue is as effective as TEA for controlling postoperative pain. Methylene blue use could help reduce PVB failure.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.14608

RETRACTED: The impact of paravertebral nerve blockade ... In conclusion, our study demonstrates that paravertebral block significantly ameliorates postoperative pain levels in patients undergoing ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1208325/full

The analgesic efficacy of erector spinae plane block versus ... The literature suggests thoracic paravertebral block (PVB) as a pain management approach. The ESPB (erector spinae plane block) is regarded to be an effective ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20947592/

Efficacy and safety of paravertebral blocks in breast surgery There is considerable evidence that PVB in addition to GA or alone provide a better postoperative pain control with little adverse effects compared with other

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK80093/

Efficacy and safety of paravertebral blocks in breast surgery Paravertebral blocks (alone or in combination with general anaesthetic) provided better postoperative pain control with few adverse effects compared with other ...

8. journals.lww.com journals.lww.com/clinicalpain/fulltext/2024/06000/safety_and_complications_of_landmark_based.5.aspx

Safety and Complications of Landmark-based ... Our study suggests that landmark-based paravertebral blocks for breast surgery result in a very low complication rate and are a safe technique for postsurgical ...

9. msjonline.org msjonline.org/index.php/ijrms/article/download/13950/8908/64989

Safety and effectiveness of paravertebral block for simple ... The primary outcome was postoperative pain, assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. Secondary ...

10. academic.oup.com academic.oup.com/painmedicine/article/21/12/3539/5941882

A Randomized Controlled Trial | Pain Medicine | Oxford ... Our results confirmed that PVB reduced the occurrence of CPSP at six months by 48%, further demonstrating the efficacy of PVB in preventing pain ...