- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255146
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective:
To characterize the effects of peri-operative intercostal cryoablation for the prevention of post thoracotomy pain following minimally invasive mitral valve surgery or atrial septal defect repair.
Rationale:
Minimally invasive cardiothoracic surgery is often associated with prolonged post-operative neuropathic pain not consistent with the acute pain experience of the initial surgery [1]. This is often thought to be secondary to an intercostal neuralgia caused by traction injuries to the intercostal neurovascular bundles by the surgical ports, a mini-thoracotomy, and mechanical retraction of the ribs.
Cryoanalgesia is an older but clinically relevant technique that causes local destruction of nerve axons using a nitrous oxide-cooled probe to -60°C [2]. This allows for temporary acute pain relief without damaging the endoneurium, allowing the peripheral nerves to regrow post-operatively. Previous studies have demonstrated cryoanalgesia as having improved acute post-operative pain vs opioids alone or similar acute pain management vs epidural analgesia [3,4]. A few studies have assessed Cryoanalgesia in thoracic surgery patients; however, these studies have focused primarily on lung operations involving pulmonary resections, and did not include cardiac operations [5,6]. Furthermore, studies that evaluated cardiothoracic operations specifically, were either retrospective or prospective in approach and did not include a representative variety of cardiac operations [7-9]. Therefore, we hope that by using intercostal cryoablation in minimally invasive cardiac surgery patients, we might improve post-operative pain and reduce analgesic requirements.
Sample Size and Statistical Considerations:
Analyses will be conducted on an intention-to-treat basis. Relative and absolute risk will be calculated with respect to the primary and secondary outcomes. We calculate a sample size of 50 patients per group in order to detect a reduction in incidence of post-thoracotomy pain from 50% to 20% (α=0.05, power=0.8). This includes an anticipated rate of non-completion of 15%.
Expected Results:
Based on our hypotheses and previous human RCT's, we expect intercostal cryoablation to improve post-thoracotomy pain when compared to controls. Furthermore, we expect an improvement in our secondary outcomes including sleep quality and analgesic requirements. Cryoanalgesia's efficacy in acute post-operative pain management is well documented in the neuropathic pain literature and has been used in a number of clinical trials. We hope that applying this concept to minimally invasive cardiothoracic procedures, we can see similar results in improved post-thoracotomy pain as reported by previous studies. We believe that, if successful, this project will offer an alternative and improved pain management regimen for patients undergoing minimally invasive thoracic surgery.
Significance:
The study proposed aims to provide new insight into the management of neuropathic pain associated with minimally invasive thoracic surgery. Pain -whether acute, chronic, nociceptive, or neuropathic- creates a significant burden to the patient, as well as to those around them. Our ultimate aim is to limit the overall pain experienced by patients. In doing this, we hope to influence a multitude of factors that affect patient welfare, including mood, patient safety, return to independence, return to work, etc. Many of these factors are often much more subjective and difficult to capture within the analytical framework of a clinical trial. However, it is our hope that by reducing pain, itself, we can continue to improve patient satisfaction and consequently, patient well-being.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeevan Nagendran, MD, PhD
- Phone Number: (780) 492-7605
- Email: jeevan@ualberta.ca
Study Contact Backup
- Name: Micheal Moon, MD, PhD
- Phone Number: 780-407-6861
- Email: mmoon@ualberta.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 years or older scheduled for elective minimally invasive mitral valve surgery or atrial septal defect repair.
Exclusion Criteria:
- Patients will be excluded if they are unable to fill in detailed health and pain related questionnaires, psychiatric disease preventing recall or accurate descriptions of pain, chronic pain syndromes, alcohol or illegal substance abuse, or pregnancy. Exclusion criteria also includes chronic use of opioids, allergy to morphine, bupivacaine, and/or ibuprofen, average pain during the last week >4 on a numerical rating scale from 0 to 10 with 0 indicating "no pain" and 10 indicating "the worst pain imaginable", contraindications to thoracic epidurals, prior chest surgery, or participation in another clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group: Cryoanalgesia
Patients receiving cryoanalgesia peri-operatively during minimally invasive cardiothoracic surgery
|
Cryoanalgesia will be given by applying a nitrous oxide-cooled probe (AtriCure, Inc. 2000) locally to intercostal nerves in the 4th, 5th, and 6th rib spaces after completion of the surgical repair and before surgical closure.
The probe will be cooled to -60°C and held on each location for 60 sec.
|
No Intervention: Control Group: No Cyroanalgesia
Patients receiving minimally invasive cardiothoracic surgery who do not receive cryoanalgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Pain Day 1
Time Frame: 1 day post-op
|
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
|
1 day post-op
|
Post-operative Pain Day 3
Time Frame: 3 days post-op
|
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
|
3 days post-op
|
Post-operative Pain Day 5
Time Frame: 5 days post-op
|
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
|
5 days post-op
|
Long-term Post-operative Pain
Time Frame: 6 weeks post-op
|
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory by asking the participants via phone call.
|
6 weeks post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality
Time Frame: 1 week post-op
|
Average sleep quality will be assessed by asking participants to rate their sleep over the first post-operative that they spent in-hospital.
This will be scored numerically from 0 to 10, with 0 indicating extremely poor sleep quality and 10 indicating extremely good sleep quality.
|
1 week post-op
|
Consumptions of Analgesics Day 1
Time Frame: 1 day post-op
|
Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted.
|
1 day post-op
|
Consumptions of Analgesics Day 3
Time Frame: 3 days post-op
|
Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted.
|
3 days post-op
|
Consumptions of Analgesics Day 5
Time Frame: 5 Days post-op
|
Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted.
|
5 Days post-op
|
Long-term Consumptions of Analgesics
Time Frame: 6 weeks post-op
|
Average daily consumption of analgesics, adjusted to morphine equivalents, over the 7 days prior to assessment.
|
6 weeks post-op
|
Length of Hospital Stay
Time Frame: approximately 2 weeks post-op
|
Hospital length of stay, measured in days, will be determined by their discharge date post-operatively and their date of admission.
|
approximately 2 weeks post-op
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abeline R Watkins, BSc, UofA Research/Department of Cardiac Surgery
- Principal Investigator: Andrew O'Connell, MD, UofA Department of Cardiac Surgery
Publications and helpful links
General Publications
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.
- Clemence J Jr, Malik A, Farhat L, Wu X, Kim KM, Patel H, Yang B. Cryoablation of Intercostal Nerves Decreased Narcotic Usage After Thoracic or Thoracoabdominal Aortic Aneurysm Repair. Semin Thorac Cardiovasc Surg. 2020 Autumn;32(3):404-412. doi: 10.1053/j.semtcvs.2020.01.008. Epub 2020 Jan 20.
- Guastella V, Mick G, Soriano C, Vallet L, Escande G, Dubray C, Eschalier A. A prospective study of neuropathic pain induced by thoracotomy: incidence, clinical description, and diagnosis. Pain. 2011 Jan;152(1):74-81. doi: 10.1016/j.pain.2010.09.004. Epub 2010 Nov 13.
- Muller LC, Salzer GM, Ransmayr G, Neiss A. Intraoperative cryoanalgesia for postthoracotomy pain relief. Ann Thorac Surg. 1989 Jul;48(1):15-8. doi: 10.1016/0003-4975(89)90169-0.
- Ju H, Feng Y, Yang BX, Wang J. Comparison of epidural analgesia and intercostal nerve cryoanalgesia for post-thoracotomy pain control. Eur J Pain. 2008 Apr;12(3):378-84. doi: 10.1016/j.ejpain.2007.07.011. Epub 2007 Sep 17.
- Park R, Coomber M, Gilron I, Shanthanna H. Cryoanalgesia for postsurgical pain relief in adults: A systematic review and meta-analysis. Ann Med Surg (Lond). 2021 Aug 5;69:102689. doi: 10.1016/j.amsu.2021.102689. eCollection 2021 Sep.
- Brichon PY, Pison C, Chaffanjon P, Fayot P, Buchberger M, Neron L, Bocca A, Verdier J, Sarrazin R. Comparison of epidural analgesia and cryoanalgesia in thoracic surgery. Eur J Cardiothorac Surg. 1994;8(9):482-6. doi: 10.1016/1010-7940(94)90019-1.
- Tanaka A, Al-Rstum Z, Leonard SD, Gardiner BD, Yazij I, Sandhu HK, Miller CC 3rd, Safi HJ, Estrera AL. Intraoperative Intercostal Nerve Cryoanalgesia Improves Pain Control After Descending and Thoracoabdominal Aortic Aneurysm Repairs. Ann Thorac Surg. 2020 Jan;109(1):249-254. doi: 10.1016/j.athoracsur.2019.07.083. Epub 2019 Sep 12.
- Bucerius J, Metz S, Walther T, Doll N, Falk V, Diegeler A, Autschbach R, Mohr FW. Pain is significantly reduced by cryoablation therapy in patients with lateral minithoracotomy. Ann Thorac Surg. 2000 Sep;70(3):1100-4. doi: 10.1016/s0003-4975(00)01766-5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anesthetics, Inhalation
- Nitrous Oxide
Other Study ID Numbers
- Pro00113974
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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