Bilevel Erector Spinae Plane Block Versus Pectoserratus Block for Analgesia in Modified Radical Mastectomy

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNational Cancer Institute, Egypt

About this trial

Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Breast cancer female patients.

ASA class II and III.

Age ≥ 18 and ≤ 65 Years.

Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Disqualifiers

Patient refusal.

Age <18 years or >65 years.

BMI <20 kg/m2 and >35 kg/m2.

Major medical conditions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound guided bilevel Erector spinae plane block (ESPB)

    Procedure/Surgery

    Ultrasound guided bilevel Erector spinae plane block

  • Ultrasound guided Pectoserratus Block

    Procedure/Surgery

    ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Ultrasound guided bilevel Erector spinae plane block (ESPB)Active comparator 1 intervention
Group B: Ultrasound guided Pectoserratus Block (PSPB)Active comparator 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total post-operative morphine consumption.

The total 24-hour morphine consumption will be recorded for every patient post operative.

Time frame
24 hours after the surgery

Secondary outcomes

1

Total intra-operative fentanyl consumption

the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups

Time frame
2-3 hours (Surgery time) surgery
2

1st time opioids requested post-operative.

In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores\<3. The total 24-hour morphine consumption will be recorded for every patient.

Time frame
24 hours after the surgery
3

Changes and stability in Mean Arterial Blood Pressure (MAP)

Change in Mean Arterial Blood Pressure (MAP) in mmHg

Time frame
every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
4

Changes and stability in Heart Rate (HR)

Change in heart rate (HR) in beat\\min

Time frame
every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

Other outcomes

Sponsors and contacts

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