Opioid Use, Post Operative Pain
Conditions
Keywords
Post Operative Pain, Opioid Use
Brief summary
This prospective, randomized, assessor-blinded trial compares serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) for postoperative analgesia in unilateral breast surgery. 54 patients will be randomized to receive either SPSIPB or ESPB before general anesthesia. The primary outcome is postoperative pain scores within the first 24 hours. The secondary outcome is opioid consumption.
Detailed description
This prospective, randomized, assessor-blinded, single-center clinical trial is designed to compare the effects of serratus posterior superior intercostal plane block (SPSIPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery. Eligible adult female patients will be randomly assigned in a 1:1 ratio to receive either SPSIPB or ESPB under ultrasound guidance prior to induction of general anesthesia. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time points within the first 24 hours, both at rest and during movement. The primary outcome is postoperative pain scores within 24 hours. The secondary outcome is total opioid consumption during the same period. This study aims to determine whether SPSIPB provides comparable or superior analgesia compared to ESPB in unilateral breast surgery.
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.
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 |
|---|---|---|
| Postoperative Pain Scores (NRS) | T0: upon arrival at recovery (Aldrete ≥9), T1: 1 hour, T2: 4 hours, T3: 8 hours, T4: 12 hours, T5: 24 hours postoperatively | Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates worst imaginable pain). Pain scores will be evaluated both at rest and during movement (coughing) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | T0-T1: 0-1 hour, T1-T2: 1-4 hours, T2-T3: 4-8 hours, T3-T4: 8-12 hours, and T4-T5: 12-24 hours postoperatively | Total opioid consumption will be recorded during the first 24 hours postoperatively and expressed as intravenous tramadol consumption. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEngin Çetin, M.D.
CONTACTEngin Çetin, M.D
PRINCIPAL_INVESTIGATOREngin Çetin, M.D
Kocaeli City Hospital
Outcome results
None listed