Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)
Maneno muhimu
Kikemikali
Maelezo
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Inclusion criteria:
- Patient between 18 years to 80 years.
- Patient to myocardial revascularization by sternotomy
Exclusion criteria:
- Patitient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- Emergency surgery
- Ejecction Fraction less than 35%
- Allergy to the local anesthesic.
- Allergy to opioids
- Patient in who will be technically impossible the application of the blockade
Trial treatment:
Intervention: These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 ml (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Control:
These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Expected sample size, enrollment and expected number of centers:
Sample size = 44 Recruitment start date: 15 january of 2019 Recruitment end date: 15 July of 2019
Follow-up end date:
Number of centers: 1
Statistical considerations:
- Intention to treat analysis
- The primary outcomes will be analyzed using
Tarehe
| Imethibitishwa Mwisho: | 07/31/2019 |
| Iliyowasilishwa Kwanza: | 01/08/2019 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 01/19/2019 |
| Iliyotumwa Kwanza: | 01/22/2019 |
| Sasisho la Mwisho Liliwasilishwa: | 08/19/2019 |
| Sasisho la Mwisho Lilichapishwa: | 08/21/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 01/14/2019 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 08/29/2019 |
| Tarehe ya Kukamilisha Utafiti: | 09/29/2019 |
Hali au ugonjwa
Uingiliaji / matibabu
Other: Serrato intercostal plane Block
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| No Intervention: Conventional Analgesia These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation for handling an analgesic in cardiovascular surgery, this start in surgery with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.
and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus. | |
| Experimental: Serrato intercostal plane Block These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus | Other: Serrato intercostal plane Block Will be performed by echo guided one puncture in the fifth costal arch with anterior axilary line, where the tip of the needle will be guided until it reaches a point above the external intercostal muscle, below the anterior serratus above the costal arch where they will be administered 21 ml of anesthesic mass, (20 ml of levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone.) |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Patient between 18 years to 80 years - Patient to myocardial revascularization by sternotomy Exclusion Criteria: - Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze) - Emergency surgery - Ejection Fraction less than 35% - Allergy to the local anesthesics. - Allergy to opioids - Patient in who will be technically impossible the application of the blockade |
Matokeo
Hatua za Matokeo ya Msingi
1. Fentanyl Consume [48 hours]
Hatua za Matokeo ya Sekondari
1. Pain In Rest and in motion [48 hours]
2. Nausea and vomiting [48 hours.]
3. Sedation [48 hours.]
4. hemothorax [24 hours]
5. seizures [1 hour after block]
6. Arrhythmias [1 hour after block]
