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Analgesic EffectsEarly Phase 1NCT03734848

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

A Early Phase 1 study testing Bilateral Ultrasound Guided Pectoralis Nerve Block. in people with Analgesic Effects and Systemic Stress Response, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
What is being tested?
Bilateral Ultrasound Guided Pectoralis Nerve Block.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
Jan 2016to Nov 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • allergy to local anesthetics
  • psychiatric illness
  • patients with prolonged postoperative ventilator course

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ahmed Said Elgebaly

    Tanta

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Bilateral Ultrasound Guided Pectoralis Nerve Block.
Keywords
Pectoralis block, Opioids Consumption, off-pump

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT03734848
Study groupRoleWhat they receive
Group 1No interventionpatients did not receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).
Group 2Active comparatorpatients receive Bilateral Ultrasound Guided Pectoralis Nerve Block (control group).
Receives: Drug: Bilateral Ultrasound Guided Pectoralis Nerve Block.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Heart rate.

    Ranges of heart rate will be estimated in beat per minutes.

    Measured: 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

  2. changes in mean arterial blood pressure and cardiac indices.

    Ranges of mean arterial blood pressure estimated in mmHg.

    Measured: 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

  3. 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).

    Measured: 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

  4. 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)

    Measured: 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

  5. changes in Plasma levels of cortisol hormone

    Ranges in Plasma levels of cortisol in (ng/mL)

    Measured: 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)

  1. changes in sufentanil consumption

    Measured by (µg/kg)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2018
  2. Study startJan 2016
  3. Primary completionJan 2018
  4. Study completionNov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03734848
Sponsor's protocol ID
TantaS
Status last verified
Nov 2018
First submitted
31 Oct 2018
Last updated
8 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30052231

  • 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.

    PubMed 22939099

  • 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.

    PubMed 29628849

  • 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.

    PubMed 27543533

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Bilateral Ultrasound Guided Pectoralis Nerve Block. in people with Analgesic Effects and Systemic Stress Response, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Heart rate. (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03734848, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.

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