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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Vascular Access Device
• Intervention / Treatment: Procedure: Serratus Posterior Superior Intercostal Plane Block; Procedure: Local Anesthetic Infiltration

Detailed Description

This prospective, randomized controlled study evaluates the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block compared with standard local anesthetic infiltration in patients undergoing port catheter implantation. Although the procedure is usually performed under local anesthesia, patients may experience significant pain during port pocket creation.

Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided SPSIP block or local anesthetic infiltration. All patients will receive standardized monitoring and premedication. Pain intensity during different procedural stages, postoperative pain scores, analgesic consumption, and satisfaction levels will be assessed.

The study aims to determine whether SPSIP block improves intraoperative analgesia and reduces analgesic requirements compared to local infiltration.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Acil, M.D.; Phone Number: +905337225225; Email: acilfatma@gmail.com

Study Locations

• Turkey (Türkiye)
  • Outside of the US
    • Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
      • Recruiting
      • Fatma Acil
      • Contact: Fatma Acil, M.D.; Phone Number: +05337225225; Email: acilfatma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local Infiltration; Participants will receive standard local anesthetic infiltration during port catheter implantation.	Procedure: Local Anesthetic Infiltration; Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
Experimental: Serratus Posterior Superior Intercostal Plane Block; Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation.	Procedure: Serratus Posterior Superior Intercostal Plane Block; Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.; Other Names: SPSIP Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum intraoperative pain score	The highest pain intensity recorded during any procedural stage will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.	During the procedure
Pain intensity during procedural stages	Pain intensity will be assessed during skin puncture, catheter tunneling, and skin closure using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.	During the procedure
Total supplemental local anesthetic amount	Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters.	During the procedure
Postoperative pain scores	Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.	0, 2, 6, 12, and 24 hours after the procedure
Total tramadol consumption	Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams.	Within 24 hours after the procedure
Duration of effective analgesia	Duration of effective analgesia will be defined as the time interval from completion of the procedure to the first administration of rescue analgesia.	Within 24 hours after the procedure
Patient satisfaction score	Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction.	After the procedure
Surgeon satisfaction score	Surgeon satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction.	After the procedure
Procedure-related complications	Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded.	During and within 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Investigators: Principal Investigator: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 16, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Serratus posterior superior intercostale plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 07/04/2026-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No