Comparing Post-operative Analgesia After (PECS II) Block and (ESPB) in Modified Radical Mastectomy

Ain Shams University

Status: Completed

Conditions: Anaesthesia

Treatments: Procedure: Erector spinae plane block group.; Procedure: Modified Pectoral Plane block group

Study type: Interventional

Funder types: Other

Identifiers

NCT06714682

FMASU MS458/2024

Details and patient eligibility

About

The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.

Full description

During MRM , some of the nerves in the chest are affected so most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery is an independent risk factor in the development of chronic post-mastectomy pain , not only increasing the risk of persistent agony and prolongs hospitalization, it also affects recovery and increases healthcare costs .

Multimodal techniques for pain management have been recommended by the American Society of Anesthesiologists (ASA) for the management of acute postoperative pain . These techniques include oral analgesics as opioids, paracetamol and nonsteroidal anti inflammatory drugs (NSAIDs) , intravenous (IV) and regional analgesia. Inappropriate postoperative analgesia may increase morbidity and mortality .

PECS-II block is an interfascial plane block in which local anesthetic is injected between serratus anterior and pectoralis muscles that blocks the pectoral nerve as well as the long thoracic, intercostobrachial and lateral cutaneous branches of the inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to be performed alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides safe and adequate post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, vascular puncture, infection, local anesthetic systemic toxicity (LAST), allergy and failed block .

ESPB is a paraspinal fascial plane block in which local anesthetic is injected between the tip of the transverse process of the spine and the anterior fascia of the erector spinae muscles blocking the dorsal and ventral rami of the spinal nerves, as well as the sympathetic chain, resulting in analgesia of chronic thoracic neuropathic pain, breast and upper abdominal surgeries. The block, defined by Forero et al., can cover several spinal nerve levels above and below the injection site as the local anesthetic spreads along the fascial plane, depending on the volume and concentration of the local anesthetic . The main advantages of this technique include the ease of performing it, the analgesic efficacy and the low risk of complications as Pneumothorax, hemi-diaphragmatic paralysis, motor weakness, and neurological findings related to local anesthesia toxicity .

Enrollment: 20 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients scheduled for MRM.
2. Age eligible ≥ 40 & ≤ 65 yrs.
3. Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.

Exclusion criteria

1. Age < 40 & > 65 years old.
2. Declining to give written informed consent.
3. History of allergy to the medications used in the study.
4. Contraindication to regional anesthesia [including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection].
5. Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2).
6. Renal dysfunction [GFR < 50 ml/min calculated by MDRD (Modification of diet in renal disease) equation for GFR estimation (Livio et al., 2008)].
7. Psychiatric disorder.
8. Pregnancy.
9. Patient with history of thoracic spine surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Ultrasound-Guided Modified Pectoral Plane Block group

Active Comparator group

Description:

first group 10 patients

Treatment:

Procedure: Modified Pectoral Plane block group

Erector Spinae Plane Block group

Active Comparator group

Description:

second group 10 patients

Treatment:

Procedure: Erector spinae plane block group.