Postoperative Complications, Postoperative Pain, Acute
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDURELocal 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.
PROCEDURECryo-analgesia and intercostal nerve 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 1.2 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.
PROCEDURESerratus plane catheter blocks and intercostal nerve blocks
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.
PROCEDUREThoracic epidural catheter
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.
Sponsors
Swedish Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The randomization method will be sealed opaque envelopes with computer generated numbers inside that will have been created at the start of the study. The envelopes will be kept in the Thoracic Surgery clinic by the research coordinator. At the time of randomization, the envelope will be picked from random for each patient designating which group they will be assigned to. The anesthesia team, the thoracic surgeon performing the surgery, and the thoracic surgery clinical fellows for the study will be made aware of what arm the subject is part of for preoperative planning.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Change Over Time | Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4. | 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. |
| Post Operative Pain | Baseline (Prior to OR) | 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. |
| Post Operative Pain Day 1 (AM) | Post Operative 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. |
| Post Operative Pain Day 1 (PM) | Post Operative Day 1 (PM) | 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. |
| Post Operative Pain Day 2 (AM) | Post Operative Day 2 (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. |
| Post Operative Pain Day 2 (PM) | Post Operative Day 2 (PM) | 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. |
| Post Operative Pain Day 3 (AM) | Post Operative Day 3 (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. |
| Post Operative Pain Day 3 (PM) | Post Operative Day 3 (PM) | 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. |
| Post Operative Pain Day 4 (AM) | Post Operative Day 4 (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. |
| Post Operative Pain Day 4 (PM) | Post Operative Day 4 (PM) | 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. |
Countries
United States
Contacts
Primary ContactBrian Louie, M.D.
Backup ContactMeagan Ivy, M.D.
Outcome results
None listed