NCT07579572

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress23%
May 2026Jun 2026

First Submitted

Initial submission to the registry

May 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 16, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 5, 2026

Last Update Submit

May 16, 2026

Conditions

Keywords

Postoperative PainSerratus posterior superior intercostale plane block

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

EXPERIMENTAL

Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Local Infiltration

ACTIVE COMPARATOR

Participants will receive standard local anesthetic infiltration during port catheter implantation.

Procedure: Local Anesthetic Infiltration

Interventions

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

Also known as: SPSIP Block
Serratus Posterior Superior Intercostal Plane Block

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

Local Infiltration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Fatma Acil, M.D.

    Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Acil, M.D.

CONTACT

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
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIP block) or local anesthetic infiltration. Both groups will undergo the procedure under standardized conditions, and outcomes will be compared between parallel groups.
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

Locations