Chronic Pain Clinical Trial
— EPOCHOfficial title:
Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial
NCT number | NCT06028126 |
Other study ID # | 23-038 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2023 |
Est. completion date | August 2025 |
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
Status | Recruiting |
Enrollment | 310 |
Est. completion date | August 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients undergoing cardiac surgery via median sternotomy Exclusion Criteria: - Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.) - Emergency procedures (surgery within 2 hours) - Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study - Weight < 50kg - Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections - Surgery for infective endocarditis - Pregnancy or nursing - Chronic opioid/narcotic use > 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes - Allergies to amide anesthetic agents or any components of study interventions - Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.) - Receipt of an investigational drug or device within past 7 days |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto |
Canada,
Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x. — View Citation
Bovill JG, Sebel PS, Stanley TH. Opioid analgesics in anesthesia: with special reference to their use in cardiovascular anesthesia. Anesthesiology. 1984 Dec;61(6):731-55. — View Citation
Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445. — View Citation
Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7. — View Citation
Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153. — View Citation
Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017. — View Citation
Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30. — View Citation
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Zhang Y, Min J, Chen S. Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial. Pain Med. 2022 Mar 2;23(3):440-447. doi: 10.1093/pm/pnab291. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time from catheter insertion to extubation | Measured time from catheter insertion to extubation | from time of catheter insertion until extubation | |
Other | Time from catheter insertion to first analgesic request | Measured time from catheter insertion to first analgesic request | immediately after the intervention | |
Other | Time from catheter insertion to mobilization | Measured time from catheter insertion to mobilization | From the time of catheter insertion to mobilization | |
Other | ICU and hospital length of stay | Measured time of ICU and hospital length of stay | From date of surgery until date of ICU and Hospital discharge | |
Other | Postoperative nausea and vomiting | Measured via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse) | Up to 72 hours following catheter insertion | |
Other | Quality of Recovery-15 Scale | Assessed using Quality of Recovery-15 Scale (minimum: 0, maximum: 150; higher scores mean a better outcome) | Post-operative day 4-7 | |
Other | Post thoracotomy Pain | Assessed using McGill Pain Questionnaire (minimum 0, maximum 78; higher scores mean a worse outcome) and Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS 29) Subsections:
Physical Function: 4-20, higher scores is better outcome. Anxiety: 4-20, higher scores is worse outcome. Depression: 4-20, higher scores is worse outcome. Fatigue: 4-20, higher scores is worse outcome. Sleep Disturbance: 4-20, higher scores is worse outcome. Ability to Participate in Social Roles and Activities: 4-20, higher scores is better outcome. Pain Interference: 4-20, higher scores is worse outcome. Pain Intensity: 0-10 higher scores is worse outcome.) |
Assessed at 3 months +/- 4 weeks | |
Primary | Cumulative postoperative opioid use up to 72 hours | Postoperative opioid use measured using Milligram Morphine Equivalent | 72 hours | |
Secondary | Median pain score | Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse) | over 72 hours post-extubation | |
Secondary | Cumulative post-operative opioid use | Measured using Milligram Morphine Equivalent | from time of catheter insertion until discharge from hospital | |
Secondary | Delirium | assessed using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist. | for 72 hours following catheter insertion | |
Secondary | Quality of Recovery-15 Scale | Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome) | 24-96 hours post surgery |
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