Pain, Postoperative Clinical Trial
— PIFBOfficial title:
Ultrasound-guided Pectoral-intercostal Fascial Plane Block for Patients With Severe Pain After Coronary Artery Bypass Graft Surgery: A Feasibility Study
Verified date | April 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pain along the sternum following opening of the chest cavity, also known as post-sternotomy pain (PSP), is a common complication after heart surgery that is associated with several negative side effects. Unfortunately, an effective and safe treatment has not yet been discovered for PSP. However, recently a regional anesthesia technique called the pecto-intercostal fascial block (PIFB) was found to be associated with improved pain relief for breast surgery. The investigators plan to assess the feasibility of using PIFB as an effective and safe treatment for PSP.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing a CABG and/or valve Surgery. - Extubated and on no assisted ventilation - NPRS equal to or greater than 5 related to sternal pain despite standard treatment - Aged 19-80 - American Society of Anesthesiologists Physical Status Classification System 1 to 4 (ASA I-IV) - Provided written informed consent - Body Mass Index < 35 kg/m^2 - Patient weight equal to or greater than 50 kg - CAM negative and RASS of +1 (restless) to -2 (light sedation) Exclusion Criteria: - A known history or allergy, sensitivity, or any other form of reaction to amide-type local anesthetics. - Suspected inability to comply with study procedures, including language difficulties, or medical history and/or concomitant disease, as judged by the investigator. - A neurological and/or vascular condition which may preclude eligibility for peripheral nerve blockade as judged by the investigator. - Coagulopathy - Previous inclusion in this study. - Participation in other clinical studies during this study or in the 14 days prior to admission to this study. - Neuromuscular disease - Thoracotomy - Mini-Sternotomy |
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. Epub 2006 Dec 22. — View Citation
Brown JR, Cochran RP, MacKenzie TA, Furnary AP, Kunzelman KS, Ross CS, Langner CW, Charlesworth DC, Leavitt BJ, Dacey LJ, Helm RE, Braxton JH, Clough RA, Dunton RF, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Long-term survival after cardiac surgery is predicted by estimated glomerular filtration rate. Ann Thorac Surg. 2008 Jul;86(1):4-11. doi: 10.1016/j.athoracsur.2008.03.006. — View Citation
de la Torre PA, García PD, Alvarez SL, Miguel FJ, Pérez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. — View Citation
Del Buono R, Costa F, Agrò FE. Parasternal, Pecto-intercostal, Pecs, and Transverse Thoracic Muscle Plane Blocks: A Rose by Any Other Name Would Smell as Sweet. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):791-792. — View Citation
Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23. Review. — View Citation
Julious, SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291.
Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. — View Citation
Liu V, Mariano ER, Prabhakar C. Pecto-intercostal Fascial Block for Acute Poststernotomy Pain: A Case Report. A A Pract. 2018 Jun 15;10(12):319-322. doi: 10.1213/XAA.0000000000000697. — View Citation
Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. Review. — View Citation
McDonald SB, Jacobsohn E, Kopacz DJ, Desphande S, Helman JD, Salinas F, Hall RA. Parasternal block and local anesthetic infiltration with levobupivacaine after cardiac surgery with desflurane: the effect on postoperative pain, pulmonary function, and tracheal extubation times. Anesth Analg. 2005 Jan;100(1):25-32. — View Citation
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x. Review. — View Citation
Scientific Abstracts and ePosters: ASRA 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting April 6-8, 2017 San Francisco, CA. Reg Anesth Pain Med. 2017; 42 (6): 802-818.
Warner L, Ritter MJ. 2017. Bilateral Pecto-Intercostal Fascial Plane Block for Acute Relief of Post-Sternotomy Pain. Scientific Abstracts and ePosters: ASRA 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting April 6-8, 2017 San Francisco, CA. Reg Anesth Pain Med. 2017; 42 (6): 802-818.
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of PIFB in reduction of PSP following Sternotomy | Defined as successful reduction of NPRS by 2 or more points | Baseline to 30 minutes post-block completion | |
Secondary | Numeric pain rating score (NPRS) | One NPRS related to post-sternotomy pain and one NPRS related to other pain (0-10 scale range, 0=no pain, 10=worst possible pain) | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Opioid and analgesic use | Dose of opioid and analgesics used before and after block | 24 hours after block or until discharge from Cardiac Surgery Intensive Care Unit (CSICU) (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Duration of block | Defined as time to first rescue analgesic | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Blood pressure | Patient blood pressure (systolic and diastolic) as shown on the vital signs monitor | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Vasopressor medications administered | Type of vasopressors given after the block (if any) | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Dose of Vasopressor medications administered | Dose of vasopressors given after the block (if any) | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Heart rate | Patient heart rate as shown on the vital signs monitor | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Respiration Rate (RR) | Patient RR as shown on the vital signs monitor | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Peripheral Capillary Oxygen (SPO2) | Patient SpO2 as shown on the vital signs monitor | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Supplemental Oxygen (O2) | Patient O2 as shown on the vital signs monitor (if any) | Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block) | |
Secondary | Most Painful Site | Patients are asked to identify the area where they feel the most pain. No scale is used, just verbal indication or by pointing to the area. | 30 minutes 12 hours and 24 hours post block if still in CSICU | |
Secondary | Confusion Assessment Method (CAM) | A valid method of monitoring/diagnosing delirium in intensive care unit patients The diagnosis of delirium by CAM requires the presence of three of the four features listed (A: Acute onset and Fluctuating course; B: Inattention; C: Disorganized thinking; D: Altered level of consciousness) | 12 hours and 24 hours post block (if still in CSICU) | |
Secondary | Loss of Sensation | The Anesthesiologist will assess if there is a loss of sensation along the sternotomy. This is done by asking if the patient can feel cold in different areas of the chest. There is no scale for this measure, it is recorded as yes or no with a description if the assessor feels it is necessary. | 30 minutes post block |
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