Serratus Posterior Superior Intercostal Plane Block in Port Catheter Implantation
Comparison of Serratus Posterior Superior Intercostal Plane Block and Local Infiltration for Analgesia During Port Catheter Implantation: A Prospective Randomized Study
1 other identifier
interventional
70
1 country
1
Brief Summary
This randomized prospective study aims to compare the analgesic efficacy of serratus posterior superior intercostal plane (SPSIP) block and standard local anesthetic infiltration in patients undergoing port catheter implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started May 2026
Shorter than P25 for not_applicable postoperative-pain
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
First Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedStudy Start
First participant enrolled
May 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 16, 2026
May 19, 2026
May 1, 2026
1 month
May 5, 2026
May 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity during port pocket creation
Pain intensity during port pocket creation measured using the Numeric Rating Scale (0-10), where higher scores indicate greater pain. Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
During procedure
Secondary Outcomes (9)
Maximum intraoperative pain score
During the procedure
Pain intensity during procedural stages
During the procedure
Total supplemental local anesthetic amount
During the procedure
Postoperative pain scores
0, 2, 6, 12, and 24 hours after the procedure
Total tramadol consumption
Within 24 hours after the procedure
- +4 more secondary outcomes
Study Arms (2)
Serratus Posterior Superior Intercostal Plane Block
EXPERIMENTALParticipants will receive an ultrasound-guided SPSIP block prior to port catheter implantation.
Local Infiltration
ACTIVE COMPARATORParticipants will receive standard local anesthetic infiltration during port catheter implantation.
Interventions
Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.
Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
Eligibility Criteria
You may qualify if:
- Age 18-75 years
- ASA physical status I-III
- Scheduled for elective port catheter implantation
- Ability to understand and use the Numeric Rating Scale (NRS)
- Provided written informed consent
You may not qualify if:
- Known allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or anticoagulant therapy
- Severe pulmonary disease
- G6PD deficiency
- Pregnancy or breastfeeding
- Inability to assess pain or communicate effectively
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatma Acil
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatma Acil, M.D.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and care providers will not be blinded due to the nature of the interventions. Investigators responsible for data analysis and outcome assessors responsible for postoperative evaluations will be blinded to group allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 12, 2026
Study Start
May 16, 2026
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
June 16, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05