Minimally Invasive Esophagectomy Pain Control Trial

Swedish Medical Center

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Postoperative Complications; Postoperative Pain, Acute

Treatments: Procedure: Thoracic epidural catheter; Procedure: Local intercostal nerve block; Procedure: Serratus plane catheter blocks and intercostal nerve blocks; Procedure: Cryo-analgesia and intercostal nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT05906134

Rib Block 21181

Details and patient eligibility

About

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.

Full description

Pilot study planned to consent 30 patients in total with a projected study timeline of 2-3 years for completion. Participants will be enrolled in the study and randomized in their preoperative clinic visit. On the day of surgery, they will receive the intervention they were randomized to. 10 patients will be randomized to the intercostal block group, 10 patients will be randomized to the cryo-ablation plus intercostal block group, and 10 patients will be randomized to the serratus plane catheter plus intercostal block group. They will be followed throughout their hospital stay until discharge for data collection purposes. Once the patient is discharged from the hospital, post-operative follow-up in the Swedish Thoracic Surgery Clinic will be collected up to 1 year post-operatively.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All adult individuals who undergo an esophagectomy with an intended minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:

• 3-hole with R video-assisted thoracoscopic surgery (VATS)
• Ivor Lewis R VATS

Exclusion criteria

• Age <18
• Unable to consent
• Additional surgical procedures planned
• Patients with previous thoracic surgery
• Patient with chronic pain on a daily regimen of narcotics
• Non-English speaking
• Contraindications to neuraxial anesthesia (ongoing anticoagulation, anticipated post-operative therapeutic anticoagulation, spinal cord stimulators, anatomic abnormalities preventing epidural placement)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

local intercostal nerve block

Active Comparator group

Description:

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.

Treatment:

Procedure: Local intercostal nerve block

Procedure: Thoracic epidural catheter

cryo-ablation plus intercostal nerve block

Active Comparator group

Description:

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.

Treatment:

Procedure: Cryo-analgesia and intercostal nerve block

Procedure: Thoracic epidural catheter

serratus plane catheter plus intercostal nerve block

Active Comparator group

Description:

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.

Treatment:

Procedure: Serratus plane catheter blocks and intercostal nerve blocks

Procedure: Thoracic epidural catheter