Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT05906134
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Esophagectomy Pain Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Operative Pain Change Over Time', 'timeFrame': 'Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4.', 'description': '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.'}, {'measure': 'Post Operative Pain', 'timeFrame': 'Baseline (Prior to OR)', 'description': '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.'}, {'measure': 'Post Operative Pain', 'timeFrame': 'Post-Op Time 0', 'description': '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.'}, {'measure': 'Post Operative Pain Day 1 (AM)', 'timeFrame': 'Post Operative Day 1 (AM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 1 (PM)', 'timeFrame': 'Post Operative Day 1 (PM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 2 (AM)', 'timeFrame': 'Post Operative Day 2 (AM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 2 (PM)', 'timeFrame': 'Post Operative Day 2 (PM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 3 (AM)', 'timeFrame': 'Post Operative Day 3 (AM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 3 (PM)', 'timeFrame': 'Post Operative Day 3 (PM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 4 (AM)', 'timeFrame': 'Post Operative Day 4 (AM)', 'description': '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.'}, {'measure': 'Post Operative Pain Day 4 (PM)', 'timeFrame': 'Post Operative Day 4 (PM)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain, Acute', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adult individuals who undergo an esophagectomy with an intended minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:\n\n* 3-hole with R video-assisted thoracoscopic surgery (VATS)\n* Ivor Lewis R VATS\n\nExclusion Criteria:\n\n* Age \\<18\n* Unable to consent\n* Additional surgical procedures planned\n* Patients with previous thoracic surgery\n* Patient with chronic pain on a daily regimen of narcotics\n* Non-English speaking\n* Contraindications to neuraxial anesthesia (ongoing anticoagulation, anticipated post-operative therapeutic anticoagulation, spinal cord stimulators, anatomic abnormalities preventing epidural placement)'}, 'identificationModule': {'nctId': 'NCT05906134', 'briefTitle': 'Minimally Invasive Esophagectomy Pain Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Swedish Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Local Intercostal Nerve Blocks, Cryo-ablation Plus Intercostal Nerve Blocks, and Serratus Plane Catheter Plus Intercostal Nerve Blocks After Minimally Invasive Esophagectomy', 'orgStudyIdInfo': {'id': 'Rib Block 21181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'local intercostal nerve block', '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.', 'interventionNames': ['Procedure: Local intercostal nerve block', 'Procedure: Thoracic epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cryo-ablation plus intercostal nerve block', '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.', 'interventionNames': ['Procedure: Cryo-analgesia and intercostal nerve block', 'Procedure: Thoracic epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'serratus plane catheter plus intercostal nerve block', '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.', 'interventionNames': ['Procedure: Serratus plane catheter blocks and intercostal nerve blocks', 'Procedure: Thoracic epidural catheter']}], 'interventions': [{'name': 'Local intercostal nerve block', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['local intercostal nerve block']}, {'name': 'Cryo-analgesia and intercostal nerve block', 'type': 'PROCEDURE', 'otherNames': ['Cryo-ablation'], 'description': '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.', 'armGroupLabels': ['cryo-ablation plus intercostal nerve block']}, {'name': 'Serratus plane catheter blocks and intercostal nerve blocks', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['serratus plane catheter plus intercostal nerve block']}, {'name': 'Thoracic epidural catheter', 'type': 'PROCEDURE', 'description': "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.\n\nAny additional pain control will be added as an adjunct to the study arm and will be noted in the data set.", 'armGroupLabels': ['cryo-ablation plus intercostal nerve block', 'local intercostal nerve block', 'serratus plane catheter plus intercostal nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Louie, M.D.', 'role': 'CONTACT', 'email': 'brian.louie@swedish.org', 'phone': '206-215-6800'}, {'name': 'Meagan Ivy, M.D.', 'role': 'CONTACT', 'email': 'megan.ivy@swedish.org', 'phone': '206-215-6800'}], 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Brian Louie, M.D.', 'role': 'CONTACT', 'email': 'brian.louie@swedish.org', 'phone': '(206) 215-6800'}, {'name': 'Meagan Ivy, M.D.', 'role': 'CONTACT', 'email': 'megan.ivy@swedish.org', 'phone': '(206) 215-6800'}], 'overallOfficials': [{'name': 'Brian Louie, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}