U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy
- Conditions
- U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block
- Interventions
- Procedure: Serratus Anterior Plane Block
- Registration Number
- NCT05006612
- Lead Sponsor
- Cairo University
- Brief Summary
We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.
- Detailed Description
Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .
The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.
Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Female patients
- Type of surgery; Modified Radical Mastectomy (MRM)
- Physical status ASA I, II, III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
- Age <18 years or >65 years
- BMI <20 kg/m2 and >35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Patient refusal.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
- Pregnancy.
- Physical status ASA IV and Male patients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 ((Serratus Anterior Plane Block SAPB) Serratus Anterior Plane Block N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%. Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block) Serratus Anterior Plane Block N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 20 ml levobupivacaine 0.25%and Modified Pectoral Nerve Block with injection of 10 ml levobupivacaine 0.25%between the two pectoralis muscles, after that, the probe was turned toward the axilla, and as the serratus anterior muscle was recognized above the third and fourth ribs, 10 mL of levobupivacaine 0.25% was injected above this muscle
- Primary Outcome Measures
Name Time Method The total amount of morphine consumption in the first 24 hours postoperatively Through Study Completion The total amount of morphine consumption in the first 24 hours postoperatively
- Secondary Outcome Measures
Name Time Method Postoperative nausea and vomiting (PONV) as side effects of morphine. Through Study Completion over the first 24 hrs postoperative Nausea and vomiting Scores using a four-point verbal scale:
Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. Through Study Completion over the first 24 hrs postoperative Change in hemodynamics ((heart rate and mean arterial blood pressure)
Patient satisfaction the patient will be classified in this group to satisfied or not. Through Study Completion over the first 24 hrs postoperative Patient satisfaction the patient will be classified in this group to satisfied or not.
Total amount of intraoperative fentanyl will be recorded. Through Study Completion over the first 24 hrs postoperative Total amount of intraoperative fentanyl will be recorded.
Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative). Through Study Completion over the first 24 hrs postoperative Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture
Time of first rescue analgesia Through Study Completion over the first 24 hrs postoperative Time of first rescue analgesia
Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading. Through Study Completion over the first 24 hrs postoperative Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.
The degree of postoperative sedation according to Ramsay scores Through Study Completion over the first 24 hrs postoperative . postoperative sedation according to Ramsay scores
Morphine related complications such as respiratory depression, urine retention or pruritis Through Study Completion over the first 24 hrs postoperative Morphine related complications such as respiratory depression, urine retention or pruritis
Trial Locations
- Locations (1)
Ahmed Abdalla Mohamed
🇪🇬Cairo, Egypt