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Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries

A

Ain Shams University

Status

Enrolling

Conditions

Regional Anesthesia Morbidity

Treatments

Procedure: costotransverse block
Procedure: serratus anterior plane block
Procedure: patient controlled analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06260397
analgesia for MRM surgeries

Details and patient eligibility

About

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

Full description

Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).

Group (A) (SAPB):

SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.

Group (B) (CTB):

CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.

Group (C) (patient controlled analgesia):

After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.

Enrollment

90 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
  2. Scheduled for modified radical mastectomy (MRM).
  3. Body weight ranging from 60 to 100 kilograms.

Exclusion criteria

  1. Declining to give a written informed consent.
  2. History of allergy to the medications used in the study.
  3. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
  4. Psychiatric disorders.
  5. Significant cognitive dysfunction.
  6. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
  7. Daily use of opioids.
  8. Obesity (BMI > 35 kg/m2).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

serratus anterior plane block
Experimental group
Description:
while the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected.
Treatment:
Procedure: serratus anterior plane block
costotransverse plane block
Experimental group
Description:
while the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected
Treatment:
Procedure: costotransverse block
patient controlled analgesia
Experimental group
Description:
After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
Treatment:
Procedure: patient controlled analgesia

Trial contacts and locations

1

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Central trial contact

Abdalla Ma Abdalla, master

Data sourced from clinicaltrials.gov

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