Rhomboid Intercostal Sub-serratus Plane Blocks and Erector Spinae Plane Block in Mastectomy Surgeries

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorNational Cancer Institute, Egypt

About this trial

Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.

Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.

Erector spinae plane block is a novel para-spinal regional anesthesia technique, , promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.

The ultrasound-guided rhomboid intercostal block sub-serratus plane block (RISS) is a novel analgesic technique The RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Breast cancer female patients.

ASA class II and III.

Age ≥ 18 and ≤ 60 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 Combined Rhomboid Intercostal Sub-serratus Plane Blocks

    Procedure/Surgery

    Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks

  • Erector Spinae Plane Block

    Procedure/Surgery

    Erector Spinae Plane Block

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Ultrasound guided Rhomboid intercostal block sub-serratus plane block (RISS).Active comparator 1 intervention
Group B: Ultrasound guided Erector spinae plane block (ESPB)Active comparator 1 intervention

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

Click on the lead sponsor to view all of their trials.