Clinical trial NCT05006612: U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy
Official title: U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy,Randomized Double Blinded Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Samuel Bekhet Moawad
name: Ahmed Shaker Ragab
name: Michael Wahib Wadid
First posted: 2021-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To determine the analgesic effect of ultrasound guided Serratus anterior block combined with modified pectoral nerve block compared to ultrasound guided Serratus Anterior block in patients undergoing modified radical mastectomy regarding the following :

1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Post-operative Numeric Pain Rating Scale.

3. Effect on hemodynamics:

Mean arterial blood pressure and Heart rate.

4. Intraoperative fentanyl consumption.

5. Duration of analgesic effect
Primary purpose: SUPPORTIVE_CARE

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 .

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The total amount of morphine consumption in the first 24 hours postoperatively
timeFrame: Through Study Completion
Secondary outcomes:
measure: Total amount of intraoperative fentanyl will be recorded.
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: The degree of postoperative sedation according to Ramsay scores
timeFrame: Through Study Completion over the first 24 hrs postoperative .
measure: Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: Postoperative nausea and vomiting (PONV) as side effects of morphine.
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: Time of first rescue analgesia
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative).
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: Morphine related complications such as respiratory depression, urine retention or pruritis
timeFrame: Through Study Completion over the first 24 hrs postoperative
measure: Patient satisfaction the patient will be classified in this group to satisfied or not.
timeFrame: Through Study Completion over the first 24 hrs postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
References: