Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT05475561
Collaborator
(none)
60
1
2
1.3
44.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound guided Pecto-intercostal- fascial plane block
  • Procedure: Ultrasound guided erector spinae plane block
  • Drug: Bupivacain
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparison of Erector Spinae Plane Block and Pecto-Intercostal Facial Plane Block For Enhanced Recovery After Sternotomy in Adult Cardiac Surgery
Actual Study Start Date :
May 25, 2022
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jul 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group (P)

Procedure: Ultrasound guided Pecto-intercostal- fascial plane block
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.

Drug: Bupivacain
local anesthetic

Active Comparator: Group (E)

Procedure: Ultrasound guided erector spinae plane block
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.

Drug: Bupivacain
local anesthetic

Outcome Measures

Primary Outcome Measures

  1. Total dose of fentanyl consumption [after 1 hour postoperative]

    Analgesic effectiveness of both blocks in median sternotomy pain

  2. Total dose of fentanyl consumption [after 24 hours postoperative]

    Analgesic effectiveness of both blocks in median sternotomy pain

Secondary Outcome Measures

  1. time to extubation [after 1 hour of removal of endotracheal tube]

    the time from ICU arrival till endotracheal extubation.

  2. ICU Length of stay [after 48 hour postoperative]

    length of intensive care unit stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • adult patients of either sex

  • aged 18-50 years

  • undergoing elective cardiac surgery via median sternotomy

Exclusion Criteria:
  • refusal to participate,

  • redo

  • urgent cardiac surgery

  • local infection of the skin at the site of needle puncture

  • allergy to bupivacaine, coagulation disorders

  • clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension

  • extubation is intentionally planned to be delayed.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haasan Elhoshy Alexandria Egypt 21615

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandria University
ClinicalTrials.gov Identifier:
NCT05475561
Other Study ID Numbers:
  • 0305600
First Posted:
Jul 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022