Clinical trial NCT06028126: Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-operative Pain
Post-operative Delirium
Post-cardiac Surgery
Chronic Pain
Opioid Use Disorder
Anesthesia, Local
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:

1. cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME)
2. median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion
3. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative postoperative opioid use up to 72 hours
timeFrame: 72 hours
Secondary outcomes:
measure: Median pain score
timeFrame: over 72 hours post-extubation
measure: Cumulative post-operative opioid use
timeFrame: from time of catheter insertion until discharge from hospital
measure: Delirium
timeFrame: for 72 hours following catheter insertion
measure: Quality of Recovery-15 Scale
timeFrame: 24-96 hours post surgery
Other outcomes:
measure: Time from catheter insertion to extubation
timeFrame: from time of catheter insertion until extubation
measure: Time from catheter insertion to first analgesic request
timeFrame: immediately after the intervention
measure: Time from catheter insertion to mobilization
timeFrame: From the time of catheter insertion to mobilization
measure: ICU and hospital length of stay
timeFrame: From date of surgery until date of ICU and Hospital discharge
measure: Postoperative nausea and vomiting
timeFrame: Up to 72 hours following catheter insertion
measure: Quality of Recovery-15 Scale
timeFrame: Post-operative day 4-7
measure: Post thoracotomy Pain
timeFrame: Assessed at 3 months +/- 4 weeks
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Ahmad Alli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
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.
citation: 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.
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.
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.
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.
citation: 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.
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.
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.