Coronary Artery Disease, Pain, Postoperative
Conditions
Keywords
Pain, Postoperative, Surgery, Cardiac, Nerve, Block
Brief summary
In patients undergoing open cardiac surgery, pain control is an essential part of the enhanced recovery process. The current study aimed to evaluate the analgesic efficacies of ultrasound-guided pecto-intercostal fascial block and ultrasound-guided transversus thoracic muscle plane block for open cardiac surgeries. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intraoperative and 24 h postoperative opioid consumption.
Detailed description
It has been reported that the TTMP block and PIF block produce effective postoperative analgesia for open cardiac surgeries. The hypothesis of our study; PIF block reduces pain and analgesic consumption in the acute period (0-24 hours) similar to TTP block in patients undergoing elective cardiac surgery requiring median sternotomy. Patients will be divided into two groups: Group PIFB: A bilateral PIF block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours. Group TTMPB: A bilateral TTMP block will be performed intraoperatively (20 ml, %0.25 bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
Interventions
PROCEDURESingle-injection, ultrasound-guided bilateral PIF block.
PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.
PROCEDURESingle-injection, ultrasound-guided bilateral TTMP block.
TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients. Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients randomly will be classified into two groups using opaque sealed envelopes. Randomization will be performed using a computer-generated random number list, and a statement indicating the patient's group is placed in a closed envelope numbered according to the result. Each patient will be asked to choose an envelope, and the patients will be assigned to the study according to the group written in the envelope. An anesthesiologist with expertise in regional anesthesia will perform PIF and TTP block to ensure the block's quality and consistency.
Intervention model description
The patients will be randomly classified into two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery with median sternotomy +/- valve replacement or isolated valve surgery) * BMI \<35 kg / m2
Exclusion criteria
* Emergent surgeries, redo cases, minimally invasive procedures * Patients who do not want to participate * Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale) * Hypersensitivity or history of allergies to local anesthetics * Patients with severe major organ dysfunction (such as renal or hepatic insufficiency) * LVEF \<30 * Patients with psychiatric disorders * Pregnancy or breastfeeding * Presence of hematological disease * Patients with alcohol-drug addiction * Patients who use daily opioids for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption in the first 24 hours after surgery | Postoperative day 1 | Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | Postoperative Day 1 | The patients will be verbally evaluated according to a descriptive five-point PONV scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is registered, ondansetron 4 mg IV will be administered and repeated after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once. |
| Patient satisfaction | Postoperative Day 1 | Patients' satisfaction with pain management will be evaluated with a 5-point verbal satisfaction scale at the end of 24 hours. The Likert scale is 5 = very satisfied, 4 = satisfied, 3 = unsure, 2 = dissatisfied, 1 = very dissatisfied. |
| The number of patient required rescue analgesic | Postoperative Day 1 | The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation. |
| Postoperative pain: NRS score | Postoperative Day 1 | Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation.In addition, the time until first analgesic requirement will be recorded. The NRS is an 11-point numeric scale which ranges from 0 to 10. |
| Length of stay in the ICU | The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days | Total duration of stay in ICU will be recorded. |
| Length of stay in the hospital | Measured in days admitted in the hospital, an average of 7 days | Their stay in the hospital will be recorded. |
| The number of patients with complications | Postoperative 7 days on an average | The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded. |
| Time to extubation | Postoperative Day 1 | After the operation, the time until the patient is extubated will be recorded. |
Countries
Turkey (Türkiye)
Outcome results
None listed