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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different methods to manage pain after esophagectomy, a procedure to remove part of the esophagus. It compares three approaches: intercostal nerve blocks (pain relief injections near the ribs), cryo-ablation (freezing pain nerves) combined with nerve blocks, and serratus plane catheter blocks (a continuous pain relief method) with nerve blocks. The trial targets patients planning to undergo an esophagectomy using minimally invasive techniques, who have no history of chronic pain treated with narcotics or previous chest surgery. The goal is to identify the best pain management strategy to enhance recovery. As a Phase 1, Phase 2 trial, it focuses on understanding the treatments' mechanisms and measuring their effectiveness in an initial group, offering participants a chance to contribute to innovative pain management solutions.

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.

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

Research shows that the treatments tested in this trial have been safe in earlier studies.

Many studies have found the local intercostal nerve block to be safe and effective at reducing pain after chest surgery. It helps relieve pain and reduces the need for opioids, which are strong painkillers.

Cryo-analgesia combined with intercostal nerve blocks has also demonstrated good safety results. Studies found that this combination provides effective pain relief with fewer side effects, such as nausea, compared to using opioids alone.

The serratus plane catheter blocks, used with intercostal nerve blocks, have been studied as well. Research shows this combination is safe and reduces the need for opioids while effectively managing pain after surgery.

In summary, these treatments have been well-tolerated in past studies and offer good pain control with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these pain control methods for esophagectomy patients because they offer innovative approaches to managing postoperative pain. Unlike traditional pain management techniques like systemic opioids and standard epidural anesthesia, cryo-analgesia and intercostal nerve blocks target nerve pathways directly, potentially reducing pain with fewer systemic side effects. The serratus plane catheter combined with intercostal nerve blocks provides a continuous local anesthetic infusion, which may offer more consistent pain relief over several days. These methods aim to enhance recovery, minimize opioid use, and improve patient comfort compared to conventional treatments.

What evidence suggests that this trial's pain control methods could be effective for postoperative esophagectomy pain?

Research has shown that intercostal nerve blocks (ICNB), one of the methods tested in this trial, can effectively reduce pain in adults after chest surgery, providing significant relief within the first 24 hours. Another method under study, cryoanalgesia combined with ICNB, might offer even better pain relief and reduce the need for opioids compared to ICNB alone. Additionally, using serratus plane catheter blocks along with ICNB, also tested in this trial, can improve pain control right after surgery and decrease opioid use. Each of these methods shows promise for managing pain after esophagectomy, offering different benefits in terms of pain relief and reduced medication needs. ^{3 6 7 8 9}

Who Is on the Research Team?

Brian Louie, MD

Principal Investigator

Swedish Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10586998/

Analgesia in esophagectomy: a narrative review - PMC Cryoanalgesia involves cooling of nerves to inhibit peripheral nerve function, with subsequent pain relief. It is usually performed by intraoperatively exposing ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2049080121006397

Review Cryoanalgesia for postsurgical pain relief in adults Cryoanalgesia may be associated with better pain relief and opioid reduction than intercostal nerve blocks. •. Despite its potential for prolonged pain relief, ...

3. researchgate.net researchgate.net/publication/374243277_Analgesia_in_esophagectomy_a_narrative_review

(PDF) Analgesia in esophagectomy: a narrative review Future studies should focus on the efficacy of paravertebral and erector spinae blocks for postoperative pain management for esophagectomy.

4. academic.oup.com academic.oup.com/ejcts/article/43/3/e64/718244

Comparison of non-divided intercostal muscle flap and ... Both NIMF and INC treatments were effective and safe for the treatment of acute pain after oesophagectomy. NIMF was the better technique in ...

5. ctv.veeva.com ctv.veeva.com/study/minimally-invasive-esophagectomy-pain-control-trial

Minimally Invasive Esophagectomy Pain Control Trial A pilot randomized controlled trial comparing intercostal nerve blocks, cryo-ablation plus intercostal nerve blocks, and serratus plane ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8361293/

Cryoanalgesia for postsurgical pain relief in adults Cryoanalgesia with opioids also resulted in less postoperative nausea compared to opioid analgesia alone (relative risk [RR] 0.23, 95 % CI 0.06 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264104/

Clinical Outcomes of Cryo Nerve Ablation Technique for Pain ... Good clinical outcomes were observed in patients undergoing isolated left thoracotomy CABG with cryoICE™ utilization, including a very low incidence of post- ...

8. cdn.amegroups.cn cdn.amegroups.cn/journals/pbpc/files/journals/2/articles/78340/public/78340-PB4-9547-R2.pdf

Analgesia in esophagectomy: a narrative review Randomly allocation of 200 patients to cryoanalgesia or parenteral opioids revealed a difference in pain scores for the first seven days ...

9. jtd.amegroups.org jtd.amegroups.org/article/view/78340/html

Analgesia in esophagectomy: a narrative review - Feenstra In this narrative review, we provide a comprehensive overview of the available evidence for the different analgesia regimens for esophagectomy.