Minimally Invasive Esophagectomy Pain Control Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-26

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Arthroscopic Shoulder Surgery

NCT03691922

Arthroscopic Shoulder Surgery

COMPLETED NA

Cryo Nerve Block Trial

NCT06861387

Intercostal Nerve Block Cryo Analgesia Minimally Invasive Lung Surgery

NOT_YET_RECRUITING NA

Analgesic Efficacy of Anterior Femoral, Genicular and Adductor Canal Nerve Block

NCT02548104

Pain, Postoperative

COMPLETED NA

A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.

NCT01696188

Shoulder Pain

COMPLETED NA

Distant Extrafascial Injection vs Subfascial Injection for Interscalene Block: Acute Pain Outcomes and Rates of Complications

NCT02074397

Ultrasound-guided Regional Anesthesia Shoulder Surgery Interscalene Block +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain, Acute Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Local intercostal nerve block

Intervention Type 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.

Thoracic epidural catheter

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Cryo-analgesia and intercostal nerve block

Intervention Type 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.

Thoracic epidural catheter

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Serratus plane catheter blocks and intercostal nerve blocks

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Cryo-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.

Intervention Type PROCEDURE

Serratus 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.

Intervention Type PROCEDURE

Thoracic 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cryo-ablation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No