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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
Procedure/SurgeryUltrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
Erector Spinae Plane Block
Procedure/SurgeryErector Spinae Plane Block
Treatment groups
Trial outcomes
Primary outcomes
Total post-operative morphine consumption.
The total 24-hour morphine consumption will be recorded for every patient post operative.
Secondary outcomes
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
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.
Changes and stability in Mean Arterial Blood Pressure (MAP)
Change in Mean Arterial Blood Pressure (MAP) in mmHg
Changes and stability in Heart Rate (HR)
Change in heart rate (HR) in beat\\min
Sponsors and contacts
Click on the lead sponsor to view all of their trials.