Postoperative Pain, Vascular Access Device
Conditions
Keywords
Postoperative Pain, Serratus posterior superior intercostale plane block
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.
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.
Interventions
PROCEDURESerratus Posterior Superior Intercostal Plane Block
Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.
PROCEDURELocal Anesthetic Infiltration
Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during port pocket creation | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum intraoperative pain score | 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. |
| Pain intensity during procedural stages | 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. |
| Total supplemental local anesthetic amount | During the procedure | Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters. |
| Postoperative pain scores | 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. |
| Total tramadol consumption | Within 24 hours after the procedure | Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams. |
| Duration of effective analgesia | 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. |
| Patient satisfaction score | 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. |
| Surgeon satisfaction score | 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. |
| Procedure-related complications | During and within 24 hours after the procedure | Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFatma Acil, M.D.
PRINCIPAL_INVESTIGATORFatma Acil, M.D.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Outcome results
None listed