Bilateral Ultrasound Guided Pectoralis Nerve Block Induces Hemodynamic Stability With Reducing Systemic Stress Response for Off-pump Coronary Artery Bypass Graft

Bilateral Ultrasound Guided Pectoralis Nerve Block Induces Hemodynamic Stability With Reducing Systemic Stress Response for Adult Patients Undergoing Off-pump Coronary Artery Bypass Graft

Opioids used in attenuation of the neuroendocrine stress response in patients undergoing off-pump coronary artery bypass graft (OPCAB) it produces predictable satisfactory analgesia and sedation but with side effects such as respiratory depression, drowsiness, and myocardial depression. Regional techniques may be encouraged to be anti-stress procedures and produce risk-free postoperative (OPCAB) period. Pectoralis nerve block (pecs block) appears to possess a great deal of promise for patients undergoing (OPCAB) because of low complication rates as it is less invasive regional analgesic technique when compared to paravertebral, thoracic epidural analgesia and parenteral analgesia.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Stability; Analgesic Effects; Systemic Stress Response
• Intervention / Treatment: Drug: Bilateral Ultrasound Guided Pectoralis Nerve Block.

Detailed Description

Aims: Ultrasound Guided Bilateral Pecs block would provide attenuation of the neuroendocrine stress response with hemodynamic profile stability, decreased analgesic consumption and improves patient postoperative outcomes after(OPCAB).

Materials and Methods: A prospective, single-blind, controlled study enrolled forty patients between the age groups of 25 and 65 years undergoing (OPCAB) through midline sternotomy under general anesthesia and randomly allocated into two groups with 20 in each group. Group 1 patients did not receive Pecs block (control group), patients were anesthetized to keep the heart rate and blood pressure within 25% of the baseline values. Whereas Group 2 patients received bilateral Pecs block preoperatively. Patients were extubated once they fulfilled extubation criteria. Heart rate, mean arterial blood pressure, Plasma levels of adrenocorticotropic hormone(ACTH) and cortisol, sufentanil consumption were determined at the following points: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), at the end of surgery. Ventilator duration, duration of ICU stay hospital stay were recorded postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Ahmed Said Elgebaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing first-time OPCAB surgery.
• patients with good or only slightly reduced left ventricular function (ejection fraction _40%, left ventricular end-diastolic pressure _15 mmHg)
• patients below 75years of age

Exclusion Criteria:

• patients requiring CPB either electively or during the course of surgery
• patients with renal insufficiency (creatinine _1.5 mg/dL) or hepatic impairment (alanine aminotransferase or aspartate aminotransferase _40 U/mL)
• patients who misused alcohol or drugs
• patients with hemodynamic instability
• symptoms of congestive cardiac failure
• preexisting infection at the block site
• allergy to local anesthetics
• psychiatric illness
• patients with prolonged postoperative ventilator course

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1; patients did not receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).
Active Comparator: Group 2; patients receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).	Drug: Bilateral Ultrasound Guided Pectoralis Nerve Block.; Using a 20-gauge 5 cm needle. Injection bupivacaine 0.25% used as a local anesthetic. The block was performed in a supine position with the arm slightly abducted. The ultrasound probe was placed at the midclavicular level infero-laterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib. The needle was inserted in-plane with respect to the ultrasound probe. A volume of 20 ml of local anesthetic solution was deposited in the fascial plane between pectoralis minor and serratus anterior muscle, followed by withdrawal of the needle to the fascial plane between the pectoralis major and pectoralis minor muscle, where a volume of 10 ml was deposited. The block was performed similarly on the opposite side. Care was taken not to cross the toxic dose of bupivacaine (3 mg/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Heart rate.	Ranges of heart rate will be estimated in beat per minutes.	Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), immediately at the end of surgery
changes in mean arterial blood pressure and cardiac indices.	Ranges of mean arterial blood pressure estimated in mmHg.	Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
changes in cardiac indices.	Ranges of Cardiac indices will be estimated as follow :CO in (L/min),Cl in (L/min/m2),SVR in (dyn•s/cm5) and PVR in (dyn•s/cm5).	Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
changes in Plasma levels of adrenocorticotropic hormone(ACTH) .	Ranges in Plasma levels of adrenocorticotropic hormone(ACTH) in (pg/mL) and cortiso in l(ng/mL)	Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery
changes in Plasma levels of cortisol hormone	Ranges in Plasma levels of cortisol in (ng/mL)	Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), immediately at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in sufentanil consumption	Measured by (µg/kg)	Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4),immediately at the end of surgery

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
• Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.
• Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.
• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: off-pump; Pectoralis block; Opioids Consumption
• Other Study ID Numbers: TantaS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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