Opioid Use, Postoperative Pain
Conditions
Keywords
Post Operative Pain, Opioid Use
Brief summary
This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.
Detailed description
This single-center, prospective, randomized, controlled, assessor-blinded study will include adult female patients scheduled for elective unilateral breast surgery. Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block or erector spinae plane block before general anesthesia. The study aims to compare the effects of these two regional anesthesia techniques on chronic postoperative pain at 3 months. Chronic pain will be assessed using the Brief Pain Inventory-Short Form.
Interventions
PROCEDURESerratus Posterior Superior Intercostal Plane Block
An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia.
An ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine.
Sponsors
Engin Çetin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient and the outcome assessor will be blinded to group allocation. The anesthesiologist performing the block will not be blinded.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block (SPSIPB) or erector spinae plane block (ESPB)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-65 years * ASA physical status I-III * Body mass index (BMI) between 18 and 35 kg/m² * Scheduled for elective unilateral breast surgery (mastectomy with or without sentinel lymph node biopsy) * Ability to understand and provide written informed consent
Exclusion criteria
* Infection at the site of block application * Known allergy to local anesthetics * Coagulopathy or anticoagulant therapy * Chronic opioid use * Pregnancy * Inability to communicate or cooperate * Refusal to participate * Failed block * Requirement of additional intraoperative analgesia outside the study protocol * Development of serious intraoperative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form | Time Frame: T0: 3 months postoperatively | Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Assessed by the DN4 Questionnaire | T0: 3 months postoperatively | Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4) questionnaire. The DN4 consists of 10 items with a total score ranging from 0 to 10 (0 = no neuropathic pain characteristics; 10 = all neuropathic pain characteristics present). Higher scores indicate a greater likelihood of neuropathic pain. A total score of 4 or higher is considered indicative of neuropathic pain. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEngin Çetin, M.D.
CONTACTEngin Çetin, M.D
PRINCIPAL_INVESTIGATOREngin Çetin, M.D
Kocaeli City Hospital
Outcome results
None listed