Minimally Invasive Esophagectomy Pain Control Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
Swedish Medical Center
Study ID
NCT05906134
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Postoperative Complications
  • Postoperative Pain, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Local intercostal nerve block — PROCEDURE
    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.
  • Cryo-analgesia and intercostal nerve block — PROCEDURE
    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 1.2 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.
  • Serratus plane catheter blocks and intercostal nerve blocks — PROCEDURE
    A total of 1.2 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 POD #1, 2, 3, 4, and 5 by the pain service.
  • Thoracic epidural catheter — PROCEDURE
    The pain service and thoracic surgery attending physician will assess if the patient's pain is not well-controlled using the pain modality they are randomized to. If additional pain control is needed, this will likely consist of a thoracic epidural catheter. Any additional pain control will be added as an adjunct to the study arm and will be noted in the data set.

Study Details

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.

Key Dates

Start date
Apr 26, 2022
Status verified
Feb 2025
Primary completion
Apr 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: local intercostal nerve block
    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.
  • Active Comparator: cryo-ablation plus intercostal nerve block
    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.
  • Active Comparator: serratus plane catheter plus intercostal nerve block
    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.

Primary Outcome Measure

Post Operative Pain Change Over Time [ Time Frame: Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Swedish Cancer InstituteSeattleWashington98104
Brian Louie, M.D.
[email protected]
206-215-6800
Meagan Ivy, M.D.
[email protected]
206-215-6800

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By research site
Swedish Cancer Institute· Seattle, WA

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