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NCT Number: NCT05006612

U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy

We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.

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Key information

Conditions

U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .

The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.

Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients
  • Type of surgery; Modified Radical Mastectomy (MRM)
  • Physical status ASA I, II, III.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion criteria

  • Age <18 years or >65 years
  • BMI <20 kg/m2 and >35 kg/m2
  • Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Patient refusal.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Pregnancy.
  • Physical status ASA IV and Male patients.

Treatment and study plan

Serratus Anterior Plane Block

Procedure

SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle.

SAPB combined with Modified Pectoral Nerve Block :

SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.

Other names: Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block

Primary outcomes

  1. The total amount of morphine consumption in the first 24 hours postoperatively

    Time frame: Through Study Completion

    The total amount of morphine consumption in the first 24 hours postoperatively

Secondary outcomes

  1. Total amount of intraoperative fentanyl will be recorded.

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Total amount of intraoperative fentanyl will be recorded.

  2. Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.

  3. The degree of postoperative sedation according to Ramsay scores

    Time frame: Through Study Completion over the first 24 hrs postoperative .

    postoperative sedation according to Ramsay scores

  4. Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Change in hemodynamics ((heart rate and mean arterial blood pressure)

  5. Postoperative nausea and vomiting (PONV) as side effects of morphine.

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Nausea and vomiting Scores using a four-point verbal scale:

  6. Time of first rescue analgesia

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Time of first rescue analgesia

  7. Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative).

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture

  8. Morphine related complications such as respiratory depression, urine retention or pruritis

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Morphine related complications such as respiratory depression, urine retention or pruritis

  9. Patient satisfaction the patient will be classified in this group to satisfied or not.

    Time frame: Through Study Completion over the first 24 hrs postoperative

    Patient satisfaction the patient will be classified in this group to satisfied or not.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ahmed Shaker Ragab
  • Michael Wahib Wadid
  • Samuel Bekhet Moawad

Registry information

Official study title

U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy,Randomized Double Blinded Comparative Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2021
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.