Post Operative Pain Clinical Trial
Official title:
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercostal nerves by compression and traction by the surgical equipment. Cryoanalgesia is long-standing technique that freezes nerves locally to temporarily block pain sensation, which is currently used to treat acute post-operative pain in lung dissections and the Nuss procedure. We intend to perform a trial to assess whether using cryoanalgesia on intercostal nerves intraoperatively, reduces post-operative pain following minimally invasive cardiothoracic surgery.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Alberta |
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. — View Citation
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. — View Citation
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative Pain Day 1 | 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 | |
Primary | Post-operative Pain Day 3 | 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 | |
Primary | Post-operative Pain Day 5 | 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 | |
Primary | Long-term Post-operative Pain | 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 | Sleep Quality | 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 | |
Secondary | Consumptions of Analgesics Day 1 | Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted. | 1 day post-op | |
Secondary | Consumptions of Analgesics Day 3 | Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted. | 3 days post-op | |
Secondary | Consumptions of Analgesics Day 5 | Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted. | 5 Days post-op | |
Secondary | Long-term Consumptions of Analgesics | Average daily consumption of analgesics, adjusted to morphine equivalents, over the 7 days prior to assessment. | 6 weeks post-op | |
Secondary | Length of Hospital Stay | 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 |
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