Minimally Invasive Esophagectomy Pain Control Trial
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwedish Medical Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
3-hole with R video-assisted thoracoscopic surgery (VATS)
Ivor Lewis R VATS
Disqualifiers
Age <18
Unable to consent
Additional surgical procedures planned
Patients with previous thoracic surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Local intercostal nerve block
Procedure/SurgeryPatients 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/SurgeryThe 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/SurgeryA 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/SurgeryThe 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.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: local intercostal nerve blockActive comparator 2 interventions
Group B: cryo-ablation plus intercostal nerve blockActive comparator 2 interventions
Group C: serratus plane catheter plus intercostal nerve blockActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Post Operative Pain Change Over Time
Compare post-operative pain score changes over time between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.
Time frame
Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4.2
Post Operative Pain
Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.
Time frame
Baseline (Prior to OR)3
Post Operative Pain
Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.
Time frame
Post-Op Time 04
Post Operative Pain Day 1 (AM)
Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.
Time frame
Post Operative Day 1 (AM)Sponsors and contacts
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Source ClinicalTrials.gov