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

NCT03734848 | Completed Early Phase 1

• 1 other identifier: TantaS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesic Effects; Systemic Stress Response; Hemodynamic Stability

Keywords

Pectoralis block; Opioids Consumption; off-pump

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• changes in sufentanil consumption

  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

Study Arms (2)

Group 1

NO INTERVENTION

patients did not receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).

Group 2

ACTIVE COMPARATOR

patients receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).

Drug: Bilateral Ultrasound Guided Pectoralis Nerve Block.

Interventions

Bilateral Ultrasound Guided Pectoralis Nerve Block. DRUG

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).

Group 2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ahmed Said Elgebaly

Tanta, Egypt

Location

Related Publications (4)

• 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.

  PMID: 30052231 RESULT

• 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.

  PMID: 22939099 RESULT

• 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.

  PMID: 29628849 RESULT

• 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.

  PMID: 27543533 RESULT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 8, 2018

Record last verified: 2018-11

Locations

EG (1)