Clinical trial NCT04108715: Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia
Official title: Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MASTECTOMY
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.

Detailed description: Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.

Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery

Exclusion Criteria:

* Patients refusal
* History of amide local anesthetics allergy
* Alcohol or drug abuse
* Chronic opioid intake
* Language barriers
* Patient with psychiatric disorders
* Contraindications for regional anesthesia
* BMI \> 40 Kg/m2
* Obstructive sleep apnea that preclude PCA opioids

Primary outcomes:
measure: Cumulative Opioid consumption in the first 24 hours.
timeFrame: 0 hours post- operative( 0 time is considered time to admission to post anesthesia care unit)
measure: Cumulative Opioid consumption in the first 24 hours.
timeFrame: 1 hour post-operative
measure: Cumulative Opioid consumption in the first 24 hours.
timeFrame: 4 hours post-operative
measure: Cumulative Opioid consumption in the first 24 hours.
timeFrame: 8 hours post-operative
measure: Cumulative Opioid consumption in the first 24 hours.
timeFrame: 24 hours post-operative
measure: Post-operative pain intensity
timeFrame: pain at 0 hour, 0 time is considered time to admission to post anesthesia care unit
measure: Post-operative pain intensity
timeFrame: pain at 1 hour post operative
measure: Post-operative pain intensity
timeFrame: pain at 4 hours post operative
measure: Post-operative pain intensity
timeFrame: pain at 8 hours post operative
measure: Post-operative pain intensity
timeFrame: pain at 24 hours post operative
Secondary outcomes:
measure: Time to patient mobilization
timeFrame: First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit)
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Ahmed Thallaj
role: PRINCIPAL_INVESTIGATOR
References: