Trial Outcomes & Findings for Comparing Post-operative Analgesia After (PECS II) Block and (ESPB) in Modified Radical Mastectomy (NCT NCT06714682)
NCT ID: NCT06714682
Last Updated: 2025-05-28
Results Overview
Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
will be evaluated postoperatively on arrival to PACU (zero time)
Results posted on
2025-05-28
Participant Flow
Twenty patients were enrolled and randomly divided into the two groups , 10 patients each .
Participant milestones
| Measure |
Modified Pectoral Plane Block Group
first group 10 patients
Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.
|
Erector Spinae Plane Block Group
second group 10 patients
Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pectoral Plane Block Group
n=10 Participants
first group 10 patients
Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.
|
Erector Spinae Plane Block Group
n=10 Participants
second group 10 patients
Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 1.9 • n=10 Participants
|
52.1 years
STANDARD_DEVIATION 7.3 • n=10 Participants
|
53.4 years
STANDARD_DEVIATION 5.33 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
weight
|
77.5 kilograms
STANDARD_DEVIATION 7.8 • n=10 Participants
|
72.8 kilograms
STANDARD_DEVIATION 7 • n=10 Participants
|
75.15 kilograms
STANDARD_DEVIATION 7.41 • n=20 Participants
|
|
height
|
169.7 centimeters
STANDARD_DEVIATION 3.9 • n=10 Participants
|
167.8 centimeters
STANDARD_DEVIATION 3.6 • n=10 Participants
|
168.75 centimeters
STANDARD_DEVIATION 3.75 • n=20 Participants
|
|
breast-side
unilateral
|
8 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
|
breast-side
bilateral
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
BMI
|
26.9 kilogram per meter squared
STANDARD_DEVIATION 2.9 • n=10 Participants
|
25.9 kilogram per meter squared
STANDARD_DEVIATION 3.0 • n=10 Participants
|
26.4 kilogram per meter squared
STANDARD_DEVIATION 2.95 • n=20 Participants
|
|
ASA Classification
ASA I = A normal healthy patient
|
4 participants
n=10 Participants
|
3 participants
n=10 Participants
|
7 participants
n=20 Participants
|
|
ASA Classification
ASA II = A patient with mild systemic disease
|
6 participants
n=10 Participants
|
7 participants
n=10 Participants
|
13 participants
n=20 Participants
|
|
operation duration
|
113.4 minutes
STANDARD_DEVIATION 33.2 • n=10 Participants
|
134.4 minutes
STANDARD_DEVIATION 15.8 • n=10 Participants
|
123.9 minutes
STANDARD_DEVIATION 26 • n=20 Participants
|
PRIMARY outcome
Timeframe: will be evaluated postoperatively on arrival to PACU (zero time)Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
Outcome measures
| Measure |
Modified Pectoral Plane Block Group
n=10 Participants
first group 10 patients
Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.
|
Erector Spinae Plane Block Group
n=10 Participants
second group 10 patients
Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.
|
|---|---|---|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.
|
0.4 score on a scale
Standard Deviation 0.5
|
0.9 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 24 hours post-operativePost-operative pain severity assessed by Visual analogue scale at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).
Outcome measures
| Measure |
Modified Pectoral Plane Block Group
n=10 Participants
first group 10 patients
Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.
|
Erector Spinae Plane Block Group
n=10 Participants
second group 10 patients
Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.
|
|---|---|---|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 2 hours postoperatively.
|
1.3 score on a scale
Standard Deviation 0.5
|
1.9 score on a scale
Standard Deviation 0.3
|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 4 hours postoperatvely.
|
1.4 score on a scale
Standard Deviation 0.5
|
3.1 score on a scale
Standard Deviation 0.3
|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 8 hours postoperatively.
|
2.8 score on a scale
Standard Deviation 0.6
|
3.8 score on a scale
Standard Deviation 0.9
|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 12 hours postoperatively.
|
2.5 score on a scale
Standard Deviation 0.7
|
3.4 score on a scale
Standard Deviation 1.1
|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 18 hours postoperatively.
|
1.9 score on a scale
Standard Deviation 0.6
|
2.9 score on a scale
Standard Deviation 0.6
|
|
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 24 hours postoperatively.
|
1.6 score on a scale
Standard Deviation 0.5
|
2 score on a scale
Standard Deviation 0.5
|
Adverse Events
Modified Pectoral Plane Block Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Erector Spinae Plane Block Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mohamed Ibrahim , Lecturer of anesthesia
Ain Shams university
Phone: 01115560811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place