Pain Control Methods for Postoperative Esophagectomy Pain

Overseen By Meagan Ivy, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Swedish Medical Center

Must not be taking: Narcotics

Disqualifiers: Age <18, Previous thoracic surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: Hospital stay until discharge

30 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. However, if you are on a daily regimen of narcotics for chronic pain, you would not be eligible to participate.

What data supports the effectiveness of the treatment for postoperative esophagectomy pain?

Research shows that cryoanalgesia, a method of freezing nerves to block pain, significantly reduces postoperative pain and narcotic use compared to other methods like local anesthetics or no nerve block. Additionally, ultrasound-guided intercostal nerve block is effective for immediate pain relief after esophagectomy. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Cryo Nerve Block (cryoNB) has been shown to be safe for pain control in various surgeries, including thoracotomy and procedures for chest deformities in adolescents. ^{4 6 7 8 9}

How does cryoanalgesia differ from other treatments for postoperative esophagectomy pain?

Cryoanalgesia is unique because it uses a freezing technique to temporarily interrupt nerve function, providing effective pain relief without the need for continuous medication. This method is more efficient than traditional nerve blocks or narcotics alone, as it reduces the need for additional pain medication and has no long-term side effects. ^{1 2 3 5 10}

What is the purpose of this trial?

A pilot randomized controlled trial comparing intercostal nerve blocks, cryo-ablation plus intercostal nerve blocks, and serratus plane catheter plus intercostal nerve blocks in patients undergoing esophagectomies with minimally invasive thoracic approaches.

Research Team

Brian Louie, MD

Principal Investigator

Swedish Cancer Institute

Eligibility Criteria

This trial is for adults who are having a minimally invasive esophagectomy at Swedish Medical Center-First Hill. Candidates should be undergoing specific surgical approaches and must be able to consent. It's not for those under 18, on daily narcotics for chronic pain, with past thoracic surgery, non-English speakers, or with conditions that rule out epidural anesthesia.

Inclusion Criteria

I am having a minimally invasive esophagectomy at Swedish Medical Center-First Hill.

Exclusion Criteria

I have more surgeries planned.

I have had surgery in my chest area before.

I take pain medication daily for chronic pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Randomization

Participants are enrolled and randomized into one of three intervention groups during their preoperative clinic visit

1 day

1 visit (in-person)

Treatment

Participants receive the assigned intervention (intercostal nerve blocks, cryo-ablation plus intercostal nerve blocks, or serratus plane catheter plus intercostal nerve blocks) on the day of surgery

Hospital stay until discharge

Post-operative Follow-up

Participants are monitored for post-operative pain and other outcomes, with follow-up data collected up to 1 year post-operatively

1 year

Regular visits at the Swedish Thoracic Surgery Clinic

Treatment Details

Interventions

• Cryo-analgesia and intercostal nerve block
• Local intercostal nerve block
• Serratus plane catheter blocks and intercostal nerve blocks
• Thoracic epidural catheter

Trial Overview The study compares different pain control methods after minimally invasive esophagectomies: intercostal nerve blocks alone, cryo-ablation plus nerve blocks, and serratus plane catheter plus nerve blocks. Patients will be randomly assigned to one of these treatment groups.

Participant Groups

Group I: local intercostal nerve block Active Control 2 Interventions

Patients receiving intercostal blocks will receive a total of 1.0 cc/kg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest/intercostal block and one-third allocated for use in the abdomen.

Group II: cryo-ablation plus intercostal nerve block Active Control 2 Interventions

Patients receiving cryo-analgesia and intercostal blocks, the patient will receive cryo-ablation prior to the intercostal block. The cryo-ablation will occur 2 cm from the sympathetic chain 2 intercostal spaces above and 2 intercostal spaces below the access incision. The patient will also receive a total of 1.0 cc/kg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest/intercostal block and one-third allocated for use in the abdomen.

Group III: serratus plane catheter plus intercostal nerve block Active Control 2 Interventions

Patients receiving serratus plane catheter blocks and intercostal nerve blocks, a total of 1.0 cc/kg of 0.25% Bupivacaine + epinephrine will be administered. A total of 20 cc of the weight-based calculation will be reserved for the serratus plane catheter. The remaining local anesthetic will be divided into two-thirds for the chest and one-third for the abdomen. Patients with serratus plane catheters will have an ongoing infusion of 0.2% ropivacaine at 8 ml per hour. The serratus plane catheters will also receive a bolus of 20 ml of 0.25% bupivacaine with epinephrine on Post Operative Day (POD) #1, 2, 3, 4, and 5 by the pain service.

Who Is Running the Clinical Trial?

Swedish Medical Center

Lead Sponsor

Trials

55

Recruited

8,500+

Findings from Research

In a study of 24 patients, those who received intercostal block using cryotherapy experienced significantly less postoperative pain compared to those who received local anesthetics or no blockade.

The nerve function interruption caused by cryotherapy was temporary, lasting no more than 30 days, and there were no adverse side effects reported, indicating a safe and effective pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for post-thoracotomy pain. Katz, J., Nelson, W., Forest, R., et al.[2019]

In a randomized study of postoperative pain management after thoracotomy, patients receiving cryoanalgesia (Group III) required significantly less narcotics compared to those receiving an internal intercostal nerve block (Group II), indicating its superior efficacy in pain relief.

Cryoanalgesia is a safe and easy method for managing pain post-thoracotomy, although it does not provide complete pain relief, making it a better option than traditional nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for post-thoracotomy pain relief. Joucken, K., Michel, L., Schoevaerdts, JC., et al.[2013]

Ultrasound-guided intercostal nerve block (ICNB) was successfully performed on 40 patients after esophagectomy, providing significant pain relief compared to sufentanil treatment, especially at 1, 2, and 4 hours post-treatment.

Patients receiving ICNB experienced lower pain scores and reduced need for sufentanil, along with fewer instances of nausea and vomiting, indicating that ICNB is a safe and effective alternative for managing post-surgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Intercostal Nerve Block Following Esophagectomy for Acute Postoperative Pain Relief in the Postanesthesia Care Unit. Zhu, M., Gu, Y., Sun, X., et al.[2019]

In a study involving 50 patients undergoing video-assisted thoracoscopic surgery (VATS), both the serratus anterior plane block (SAPB) and intercostal nerve block (ICNB) showed similar effectiveness in reducing postoperative pain, as measured by numerical pain rating scale (NRS) scores.

There were no significant differences in the cumulative use of pain medications (fentanyl and ketorolac) between the two groups, and no serious adverse events were reported, indicating both techniques are safe options for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serratus anterior plane block versus intercostal nerve block for postoperative analgesic effect after video-assisted thoracoscopic lobectomy: A randomized prospective study. Lee, J., Lee, DH., Kim, S.[2022]

Continuous infusion of local anesthetics through an extrapleural catheter is at least as effective as epidural analgesia for postthoracotomy pain relief and significantly more effective than using narcotics alone.

Other intercostal nerve blockade techniques, such as cryoanalgesia and direct nerve blocks, do not provide additional benefits compared to narcotics alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. Detterbeck, FC.[2022]

Bilateral intercostal cryo nerve block (cryoNB) was used for the first time in a 65-year-old man after open-heart surgery to help manage postoperative pain, showing its potential as an effective pain control method.

CryoNB has previously been proven safe and effective in other surgical contexts, suggesting it could be a valuable adjunctive therapy for pain management in similar thoracic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report of Cryo Nerve Block in a Patient Undergoing Full Sternotomy: A Novel Approach to Pain Control in Cardiac Surgery. Caparrelli, DJ.[2023]

In a study involving 106 adult patients undergoing video-assisted thoracoscopic surgery (VATS), the thoracic paravertebral block (TPVB) provided superior pain relief compared to the erector spinae plane block (ESPB) and intercostal nerve block (ICNB) at 24 hours post-surgery.

Both TPVB and ICNB resulted in lower morphine consumption compared to ESPB, indicating that TPVB is the most effective analgesic technique for managing postoperative pain after VATS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic Paravertebral Block Achieves Better Pain Control Than Erector Spinae Plane Block and Intercostal Nerve Block in Thoracoscopic Surgery: A Randomized Study. Turhan, Ö., Sivrikoz, N., Sungur, Z., et al.[2021]

In a study of 108 children undergoing thoracotomy for congenital heart disease, both ultrasound-guided serratus anterior plane block (SAPB) and pectoral nerves (Pecs) II block were found to be more effective than intercostal nerve block (ICNB) for managing post-thoracotomy pain, particularly in the later hours after surgery.

SAPB and Pecs II blocks not only provided longer-lasting pain relief but also required less rescue analgesia compared to ICNB, making them preferable options for pain management in pediatric cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Efficacy of Ultrasound-Guided Serratus Anterior Plane Block, Pectoral Nerves II Block, and Intercostal Nerve Block for the Management of Postoperative Thoracotomy Pain After Pediatric Cardiac Surgery. Kaushal, B., Chauhan, S., Saini, K., et al.[2019]

In a meta-analysis of four randomized controlled trials involving 203 patients, the erector spinae plane block (ESPB) significantly reduced pain scores at 48 hours post-thoracoscopic surgery compared to the intercostal nerve block (ICNB).

However, ESPB did not show a significant difference in pain scores at 24 hours, 4 to 6 hours, or 12 hours post-surgery, indicating that while it may be effective for longer-term pain relief, its immediate analgesic effects are comparable to ICNB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic comparison of erector spinae plane block with intercostal nerve block for thoracoscopic surgery: A meta-analysis of randomized controlled trials. Ma, G., Gou, J., Chen, L., et al.[2023]

In a study of 144 patients undergoing thoracotomy, those who received cryoanalgesia for pain relief required significantly less narcotics and experienced lower pain scores compared to those who received traditional bupivacaine-adrenaline blockade.

Cryoanalgesia was found to be safe, with no late nerve complications reported, suggesting it could be recommended for routine use in thoracotomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of post-thoracotomy pain by cryotherapy of intercostal nerves. Roberts, D., Pizzarelli, G., Lepore, V., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for post-thoracotomy pain. [2019]

2. Belgium pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for post-thoracotomy pain relief. [2013]

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

Ultrasound-Guided Intercostal Nerve Block Following Esophagectomy for Acute Postoperative Pain Relief in the Postanesthesia Care Unit. [2019]

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

Serratus anterior plane block versus intercostal nerve block for postoperative analgesic effect after video-assisted thoracoscopic lobectomy: A randomized prospective study. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. [2022]

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

Case Report of Cryo Nerve Block in a Patient Undergoing Full Sternotomy: A Novel Approach to Pain Control in Cardiac Surgery. [2023]

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

Thoracic Paravertebral Block Achieves Better Pain Control Than Erector Spinae Plane Block and Intercostal Nerve Block in Thoracoscopic Surgery: A Randomized Study. [2021]

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

Comparison of the Efficacy of Ultrasound-Guided Serratus Anterior Plane Block, Pectoral Nerves II Block, and Intercostal Nerve Block for the Management of Postoperative Thoracotomy Pain After Pediatric Cardiac Surgery. [2019]

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

Analgesic comparison of erector spinae plane block with intercostal nerve block for thoracoscopic surgery: A meta-analysis of randomized controlled trials. [2023]

10. Sweden pubmed.ncbi.nlm.nih.gov

Reduction of post-thoracotomy pain by cryotherapy of intercostal nerves. [2019]