Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05475561 |
| Other study ID # |
0305600 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2022 |
| Est. completion date |
July 5, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Alexandria University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The current study is designed to compare the perioperative analgesic efficacy of Erector
spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults
undergoing cardiac surgery via median sternotomy.
The primary outcome measure will be the analgesic effectiveness of both blocks in median
sternotomy pain, while the secondary outcome measures will be time to extubation, and length
of intensive care unit stay.
Description:
The patients will undergo the same preoperative preparation, intraoperative monitoring, and
anesthetic technique. Fentanyl (2 μg/kg) will be given with induction of anesthesia, and
additional increments of fentanyl 2 μg/kg will be administered if mean arterial blood
pressure or heart rate rise in response to stressful surgical stimuli greater than 20% above
baseline.
All surgeries will be performed through median sternotomy, with the same cardiopulmonary
bypass and myocardial protection technique. At the end of surgery, all anesthetics will be
discontinued, and patients will be transferred to the ICU where they will be committed to a
mechanical ventilator.
the two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE
M-TURBO). After standard chest skin disinfection, the transducer will be covered with a
sterile sleeve.
he two blocks will be performed using Linear -Array ultrasound transducer probe (SONOSITE
M-TURBO). After standard chest skin disinfection, the transducer will be covered with a
sterile sleeve.
Ultrasound guided Pecto-intercostal- fascial plane block:
The block will be performed while the patient in supine position after induction of general
anesthesia and before skin incision. The probe of the ultrasound will be placed at 2 cm
lateral to the lateral sternal border at 5th and 6th rib. On the surface plane subcutaneous
tissue is identified, while Pectoralis major muscle, Intercostal muscles and ribs are seen in
intermediate plane and lung along with pleura are identified in deep plane. A 22-gauge, 80-mm
short bevel echogenic needle is used and advanced in in-plane manner, in a caudal-to-cranial
direction, until the tip of the needle is located in the fascial plane between the pectoralis
major and internal intercostal muscle, where the local anesthetic will be injected. As the
drug will be injected, a hydro dissection of the plane is checked for. At this point, color
doppler ultrasonography will be used to help identify the internal thoracic artery and its
branches that pass through the plan.
Ultrasound guided erector spinae plane block:
The block will be done while the patient is in the sitting position before induction of
general anesthesia. A high-frequency linear ultrasound transducer will be placed in a
longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5
transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and
erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.
Local infiltration with 2% of lignocaine at the site of needle insertion will be done. Using
in-plane approach a 22 G short bevel needle will be inserted in caudal-cephalad direction,
until the tip is deep to erector spinae muscle, as evidenced by visible hydro dissection
below the muscle plane. A 20 ml of 0.25% plain bupivacaine will be injected on each side.
