Paravertebral Block for Postoperative Pain

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

Trial Summary

What is the purpose of this trial?

Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively. The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.

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.

What data supports the effectiveness of the treatment Paravertebral Block for postoperative pain?

Research shows that paravertebral block can effectively reduce pain after surgeries like breast and thoracic surgeries, and it may be safer and simpler than other methods like epidural blocks. It also helps in better pain control and recovery, with fewer complications. ^{1 2 3 4 5}

Is the paravertebral block generally safe for humans?

Paravertebral block is considered a safe method for managing postoperative pain, with fewer side effects compared to epidural blocks, such as lower risks of complications like hypotension (low blood pressure), nausea, and urinary retention. It is especially noted for its safety in patients who cannot have epidural blocks, with no reported adverse events in some studies. ^{1 3 4 6 7}

How does the paravertebral block treatment differ from other treatments for postoperative pain?

Paravertebral block (PVB) is unique because it involves injecting anesthetic near the spine to block pain signals, offering a simpler and potentially safer alternative to epidural analgesia. It can be combined with other pain relief methods and avoids complications associated with epidural catheters, making it effective for various surgeries like thoracotomy and breast surgery. ^{1 2 3 8 9}

Eligibility Criteria

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 between 18 and 70 years old.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The effect on improvement of recovery and pain scores of paravertebral block immediately before breast surgery. [2011]

3. Japan pubmed.ncbi.nlm.nih.gov

Paravertebral block via the surgical field versus epidural block for patients undergoing thoracotomy: a randomized clinical trial. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Analgesia for thoracic surgery: the role of paravertebral block. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative Paravertebral Block and Chronic Pain after Breast Cancer Surgery: A Double-blind Randomized Trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Thoracic paravertebral block (PVB) analgesia. [2018]

7. Japan pubmed.ncbi.nlm.nih.gov

[Thoracic Paravertebral Block in Patients Ineligible for Epidural Block]. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy. [2022]