Skip to main content
OpenTrials
Completed

NCT Number: NCT07579572

Serratus Posterior Superior Intercostal Plane Block in Port Catheter Implantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Vascular Access Device

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatma Acil

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block

Procedure

Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.

Other names: SPSIP Block

local anesthetic infiltration

Procedure

Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.

Primary outcomes

  1. Pain intensity during port pocket creation

    Time frame: During procedure

    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.

Secondary outcomes

  1. Maximum intraoperative pain score

    Time frame: During the procedure

    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.

  2. Pain intensity during procedural stages

    Time frame: During the procedure

    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.

  3. Total supplemental local anesthetic amount

    Time frame: During the procedure

    Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters.

  4. Postoperative pain scores

    Time frame: 0, 2, 6, 12, and 24 hours after the procedure

    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.

  5. Total tramadol consumption

    Time frame: Within 24 hours after the procedure

    Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams.

  6. Duration of effective analgesia

    Time frame: Within 24 hours after the procedure

    Duration of effective analgesia will be defined as the time interval from completion of the procedure to the first administration of rescue analgesia.

  7. Patient satisfaction score

    Time frame: After the procedure

    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.

  8. Surgeon satisfaction score

    Time frame: After the procedure

    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.

  9. Procedure-related complications

    Time frame: During and within 24 hours after the procedure

    Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

Comparison of Serratus Posterior Superior Intercostal Plane Block and Local Infiltration for Analgesia During Port Catheter Implantation: A Prospective Randomized Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.