Pain, Postoperative Clinical Trial
Official title:
Transversus Thoracis Muscle Plane Block for Acute and Chronic Pain Management in Cardiac Surgical Patients Requiring Sternotomy: a Prospective Randomized Controlled Trial
Verified date | July 2023 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sternotomy pain is usually significant after cardiac surgery. Analgesic options for sternotomy in cardiac surgery are often limited. Poorly controlled acute pain is an important factor to development of chronic postsurgical pain. The transversus thoracis muscle plane (TTP) block is a novel technique that provides analgesia to anterior chest wall. A double-blinded RCT is conducted to assess the efficacy of applying TTP block as an adjunct to analgesia in cardiac surgery.
Status | Completed |
Enrollment | 86 |
Est. completion date | April 22, 2023 |
Est. primary completion date | October 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Elective CABG, aortic valve repair/replacement, mitral valve repair/replacement, or combined CABG/valve procedure Exclusion Criteria: - emergency surgery - redo surgery - history of thoracotomy or mastectomy - history of chronic pain or regular analgesic use (except paracetamol and NSAID) - history of psychiatric illnesses or illicit drug use - renal failure with eGFR <30ml/min or on renal replacement therapy - mortality or require re-sternotomy within 24h after operation - intraoperative use of remifentanil - unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption | The total amount of opioid (mg) used during the surgery | Once at the end of the surgery | |
Secondary | Percentage blood pressure change | The percentage changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) between the baseline (before surgery) and within 10 minutes after skin incision for sternotomy | From 5 minutes before skin incision to 10 minutes after skin incision at 1 minute interval ( a total of 15 time point) | |
Secondary | Percentage heart rate change | Heart rate (HR) between the baseline (before surgery) and their peaks within 10 minutes of skin incision for sternotomy. | From 5 minutes before incision to 10 minutes after skin incision at 1 minute interval (a total of 15 time points) | |
Secondary | Morphine consumption | The amount of morphine (mg) used after the surgery for pain control | up to 72 hours postoperatively | |
Secondary | Length of hospital stay | duration of hospital stay (in days) | Immediately after the surgery up to the day of patient discharge | |
Secondary | Intensive Care unit (ICU) stay | duration of ICU stay (in hours) | Immediately after the surgery up to the time of ICU discharge | |
Secondary | Pain score | A visual analogue scale of 0-10 (0=no pain, 10=worst pain) will be used to grade the pain score. Patients will be asked to rate the intensity of postoperative pain at rest and on three maximal coughs. | At 8, 12, 24, 48 and 72 hours after TTP block and on day 7 after surgery (6 time points). | |
Secondary | Peak expiratory flow rate | Measured with a spirometer at baseline on the day before operation and postoperatively at the time of assessing pain score. The higher the result means the better the lung function of the patient. | Once as baseline on the day before operation and at 6 time points after surgery (ie. at 8, 12, 24, 48, 72 hours after block and on day 7 after surgery). | |
Secondary | Forced expiratory volume in 1 second | Measured with a spirometer at baseline on the day before operation and postoperatively at the time of assessing pain score. The higher the result means the better the lung function of the patient. | Once as baseline on the day before operation and at 6 time points after surgery (ie. at 8, 12, 24, 48, 72 hours after block and on day 7 after surgery). | |
Secondary | Brief Pain Interference Scale | It will be used to evaluate the extent of pain interfering with various components of functioning, including physical functioning, emotional functioning and sleep within the last 24 hours at 3 and 6 months after surgery (a score of 0-10; 0=no interference at all, 10= the worst interference due to pain). | at 3-month and 6-month after surgery | |
Secondary | Pain Catastrophizing Scale | Pain Catastrophizing Scale (HK-PCS) will be used to assess patients' negative cognitive-affective responses to pain within the last 24 hours at 3 and 6 months after surgery. Score 0-100 (0=no pain related anxiety; 100=most severe pain related anxiety) | at 3-month and 6-month after surgery |
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