Postoperative PainNCT07579572
Serratus Posterior Superior Intercostal Plane Block in Port Catheter Implantation
A study testing Serratus Posterior Superior Intercostal Plane Block and Local Anesthetic Infiltration in people with Postoperative Pain and Vascular Access Device, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Vascular Access Device
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Local Anesthetic Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2026to 4 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatma Acil
Diyarbakır, Outside of the US, 21070
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Vascular Access Device
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Local Anesthetic Infiltration
- Keywords
- Postoperative Pain, Serratus posterior superior intercostale plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Also called SPSIP Block
Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.
Local Anesthetic InfiltrationProcedure or surgery
Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Local Infiltration | Active comparator | Participants will receive standard local anesthetic infiltration during port catheter implantation. Receives: Procedure: Local Anesthetic Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure
Secondary outcomes (9)
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.
Measured: 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.
Measured: During the procedure
Total supplemental local anesthetic amount
Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the procedure
Procedure-related complications
Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded.
Measured: During and within 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start16 May 2026
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579572
- Sponsor's protocol ID
- 07/04/2026-123
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serratus Posterior Superior Intercostal Plane Block and Local Infiltration for Analgesia During Port Catheter Implantation: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07579572
- Acronym / sponsor ID
- 07/04/2026-123
- Conditions
- Postoperative Pain, Vascular Access Device
- Keywords
- Postoperative Pain, Serratus posterior superior intercostale plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants will receive an ultrasound-guided SPSIP block prior to port catheter implantation. |
| Local Infiltration | Active comparator | Procedure: Local Anesthetic InfiltrationParticipants will receive standard local anesthetic infiltration during port catheter implantation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Known allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or anticoagulant therapy
- Severe pulmonary disease
- G6PD deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane BlockAlso: SPSIP BlockUltrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block |
| Local Anesthetic InfiltrationStandard local anesthetic infiltration performed at the surgical site during port catheter implantation. | Procedure or surgery | Local Infiltration |
Primary outcome
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.
9 secondary outcomes
Maximum intraoperative pain score
Time frame: During the procedure
Pain intensity during procedural stages
Time frame: During the procedure
Total supplemental local anesthetic amount
Time frame: During the procedure
Postoperative pain scores
Time frame: 0, 2, 6, 12, and 24 hours after the procedure
Total tramadol consumption
Time frame: Within 24 hours after the procedure
Duration of effective analgesia
Time frame: Within 24 hours after the procedure
Patient satisfaction score
Time frame: After the procedure
Surgeon satisfaction score
Time frame: After the procedure
Procedure-related complications
Time frame: During and within 24 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Acil, M.D. principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane Block and Local Anesthetic Infiltration in people with Postoperative Pain and Vascular Access Device, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during port pocket creation (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.