Ultrasound Guided Serratus Posterior Superior Intercostal Plane Versus PECS II Block In Breast Surgeries
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of the study is to compare the analgesic effect of ultrasound guided serratus posterior superior intercostal plane (SPSIP) block and pectoral nerve (PECS II) block in different breast surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2025
CompletedFirst Submitted
Initial submission to the registry
March 30, 2025
CompletedFirst Posted
Study publicly available on registry
April 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2026
CompletedApril 17, 2026
April 1, 2026
7 months
March 30, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total morphine consumption
Total morphine consumption in first postoperative twenty four hour
first postoperative 24 hour
Bedside forced vital capacity at 2 hours after surgery
Three measurements were taken and the highest one was recorded
Two hours after surgery
Secondary Outcomes (6)
NRS pain scores for breast when reaching recovery room arrival, after 2 hour, 6 hour, 12 hour, 18 hour, 24 hour at rest and during arm movement
when reaching recovery room (average 10 minutes after surgery), after two, six, twelve, eighteen, twenty four hour
Time to first rescue opioid dose
24 hours after surgery
Incidence of chronic pain at 3 and 6 months after surgery
6 months after surgery
Block related complications and side effects
24 hours after surgery
Axilla NRS pain scores evaluated at the same time points of that for breast pain
24 hours after surgery
- +1 more secondary outcomes
Study Arms (2)
SPSIP Group
ACTIVE COMPARATORUnder complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
PECS II group
ACTIVE COMPARATORUnder complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
Interventions
Under complete aseptic technique, a high frequency linear probe will be placed adjacent to upper medial part of scapula to visualize the second and third ribs. The needle will be introduced with in plane approach, from caudal to cranial and 30 ml of 0.25% bupivacaine will be injected in the fascial plane between serratus posterior superior and intercostal muscles at the level of second and third ribs.
. Under complete aseptic technique, a high frequency linear probe will be placed in the infraclavicular region, angulated and directed laterally towards the axilla to visualize the third and fourth ribs with pectoralis major, minor and serratus anterior muscles from superficial to deep. The needle will be introduced with in plane approach from medial to lateral, 10 ml of 0.25% bupivacaine will be injected in the fascial plane between pectoralis major and pectoralis minor then the needle will be further introduced to the fascial plane between pectoralis minor and serratus anterior muscles with injection of 20 ml of 0.25% bupivacaine.
Eligibility Criteria
You may qualify if:
- Age from 21 to 70 years, both male and female.
- American Society of Anesthesiologists (ASA) Physical Status Classification System I-II.
You may not qualify if:
- Any patient refuses to participate.
- Bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases.
- Chronic opioid use.
- Patients with pulmonary diseases.
- History of allergy to local anesthetics.
- Infection at the needle entry point will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University
Tanta, Select, 1234, Egypt
Related Publications (1)
Gundogdu O, Avci O, Balci F, Tekcan MN, Kol YC. Efficacy of Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: An Evidence Based Report. J Coll Physicians Surg Pak. 2024 Mar;34(3):348-350. doi: 10.29271/jcpsp.2024.03.348.
PMID: 38462873RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double blinded study
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer at Anesthesia & Surgical ICU and Pain Medicine
Study Record Dates
First Submitted
March 30, 2025
First Posted
April 20, 2025
Study Start
February 27, 2025
Primary Completion
September 27, 2025
Study Completion
March 27, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL