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Breast CancerNCT04895397

Modified Pectoral Nerve Block Versus Serratus Plane Block

A study testing ultrasound guided Nerve Block procedure in people with Breast Cancer, run by Sohag University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves… Read more about this study

Who is it for?
Ages 20 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
ultrasound guided Nerve Block procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
20 May 2021to 20 Aug 2023
Phase
Interventional
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 20 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Breast cancer surgery.
  • Age 20 to 60 years.
  • Female patients.
  • At least 24 hours post-operative hospital admission.
  • ASA (American society of anesthesiologist) physical status classification system І to Ш.

Who cannot join

  • • Morbid obesity (body mass index > 40).
  • Impossibility of anatomical structures identification by ultrasound in a satisfactory way (there can be no distinction in the interfacial plan between serratus and pectoral muscle).
  • Opioids treatment before surgery or substance abuse.
  • Sepsis and/or infection at the puncture site.
  • Hemostasis disorders.
  • Allergy to any of the drugs used in the study.
  • Less than 24 hours postoperative hospital admission.
  • Inability to communicate with the patient.

Trial locations and contacts

No sites are listed yet.

mohammed hussein, lecturer contact

01005872429

mohamedhussin@med.sohag.edu.eg

mohamed hussein, lecturer contact

01005872429

mohamedhussin@med.sohag.edu.eg

About this study

Official title: Modified Pectoral Nerve Block Versus Serratus Plane Block for Analgesia After Breast Cancer Surgeries

In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012).

In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).

Read the detailed description

One hour before induction of anesthesia 4ml blood sample will be taken from all patient to measure serum cortisol and serum endorphin level 2ml for each.

General anesthesia will be induced for all patients in both groups using the same protocol.

Anesthesia will be induced with propfol (2-3 mg/kg), IV rocuroniom (.5 - .8 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained with isoflurane (1-2 mac) in 100% oxygen.

All patients will be intubated and mechanically ventilated using volume controlled positive pressure ventilation with a tidal volume of 6-8 ml/kg and an inspiratory to expiratory ratio of 1:2 targeting end tidal carbon dioxide tension around 35mmhg.

Basic monitoring for all patients include under pulse oximetry, non-invasive blood pressure, 5 lead electrocardiogram and end tidal carbon dioxide monitoring.

In group A patients, an ultrasound guided modified pectoral nerve block will be performed after induction of general anesthesia. Under sterile conditions, US-guided PECSII block will be on the same side of surgery with the patient lying in the supine position with the ipsilateral arm abducted and externally rotated, and the elbow flexed 90°. The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.

After identification of the Pectoralis major muscle, Pectoralis minor muscle and the plane in between, the probe will be tilted caudally to identify the pulsating pectoral branch of the thoracoacromial artery, if not identified, the probe will be moved 1-2 cm caudally and medially. In a caudal tilt, the artery will be easily identified in a biconvex space.

The skin at the point of entry was infiltrated using lidocaine 1%; then, the needle (disposable spinal needle, K-3 point type LUER-Lock HUB 22G) will be advanced in an in-plane technique targeting the space in which the artery is located. Two mL of saline 0.9% will be injected to confirm the location, produce hydro-dissection, and improve needle visualization. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.

Then, the probe will be moved laterally and caudally towards the anterior axillary fold, parallel to the deltopectoral groove, until the serratus muscle appears underneath the Pectoralis minor muscle attached to the underlying ribs.

The 3rd, fourth ribs and the pleura will be then identified. After infiltration of the skin with lidocaine 1%, the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.

Group B: In SAPB Group, a US-guided serratus block will be done with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.

The ribs, pleura, and overlying serratus muscle will be identified, and the needle will be advanced cephalad in-plane until the tip touched the 4th rib. Afterward, 2 mL saline 0.9% will be injected; then, 20 mL of bupivacaine 0.25% will be injected in the plane between the serratus and the 4th rib.

At the end of the surgery, the muscle relaxant will be reversed using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After fully awake extubation, all patients will be transferred to the post-anesthesia care unit (PACU).

Two hour post-operative 4ml blood sample will be taken from all patients to measure serum cortisol and serum endorphin level 2ml for each.

Conditions
Breast Cancer
Being tested
ultrasound guided Nerve Block procedure
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ultrasound guided Nerve Block procedureDevice

    In group A patients, an ultrasound guided modified pectoral nerve block will be performed Under sterile conditions, US-guided PECSII block will be on the same side of surgery . The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.

    the needle will be advanced in an in-plane technique targeting the space in which the artery is located. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.

    the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.

    Group B: In SAPB Group, a US-guided serratus block will be done The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.

Study groups in NCT04895397
Study groupRoleWhat they receive
Group A: (30 patients)Active comparatormodified pectoral nerve block will be done.
Receives: Device: ultrasound guided Nerve Block procedure
Group B: (30 patients)Active comparatorserratus plane block will be done.
Receives: Device: ultrasound guided Nerve Block procedure

What is being measured

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

  1. assess analgesic effect of nerve block

    We assess the analgesic effect by VAS ( visual analogue scale )

    Measured: 24hour post-operative

Timeline

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

  1. First posted20 May 2021
  2. Study start20 May 2021 (estimated)
  3. Primary completion20 Jun 2023 (estimated)
  4. Study completion20 Aug 2023 (estimated)

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
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: (30 patients) modified pectoral nerve block will be done. Group B: (30 patients) serratus plane block will be done.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895397
Sponsor's protocol ID
soh-Med-21-02-05
Status last verified
May 2021
First submitted
24 Apr 2021
Last updated
20 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound guided Nerve Block procedure in people with Breast Cancer, run by Sohag University.

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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

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

Contact mohammed hussein, lecturer (01005872429, mohamedhussin@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess analgesic effect of nerve block (time frame: 24hour post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 May 2021.

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Clinical Trial NCT04895397 | AzTrials