Postoperative Pain
Conditions
Keywords
Serratus Posterior Superior Intercostal Plane Block, Erector Spinae Plane Block, Mastectomy, Postoperative Pain, Fascial Plane Block
Brief summary
Postoperative pain after mastectomy remains a significant clinical problem that may impair patient comfort and delay early rehabilitation, potentially affecting functional recovery. Various analgesic techniques are used to manage postoperative pain. This study aims to compare serratus posterior superior intercostal plane block and erector spinae plane block, which are routinely used in our clinic for postoperative analgesia in patients undergoing mastectomy, in terms of ease of application and patient comfort.
Detailed description
Postoperative pain following mastectomy is a common and clinically significant issue that not only reduces patient comfort but may also hinder early mobilization and rehabilitation, thereby negatively impacting overall functional outcomes. Effective postoperative analgesia is therefore a key component of perioperative care in breast surgery. A variety of analgesic techniques, including systemic analgesics and regional anesthesia methods, are currently employed to manage postoperative pain. Among these, ultrasound-guided fascial plane blocks have gained increasing popularity due to their relative safety, simplicity, and effectiveness. The serratus posterior superior intercostal plane (SPSIP) block and the erector spinae plane (ESP) block are two such regional techniques used for thoracic analgesia. In our clinical practice, both SPSIP and ESP blocks are routinely used for patients undergoing mastectomy. However, comparative data regarding their ease of application and impact on patient comfort are limited. Ease of application is an important consideration for anesthesiologists, particularly in busy clinical settings, while patient comfort during block placement is a critical but often underreported outcome. The primary aim of this study is to compare SPSIP block and ESP block in patients undergoing mastectomy in terms of ease of application and patient comfort during the procedure. Secondary considerations may include block-related characteristics and their contribution to postoperative recovery.
Interventions
PROCEDURESerratus posterior superior intercostal plane block
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.
PROCEDUREErector Spinae Plane Block
Participants in this group will receive an ultrasound-guided erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The block will be performed under standardized conditions prior to surgery according to the study protocol.
Sponsors
Sakarya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This study is designed as a triple-blind trial. Participants, perioperative care providers, and outcome assessors will be blinded to group allocation. Randomization will be performed using a computer-generated sequence, and group assignments will be concealed in sealed, opaque envelopes. The anesthesiologist performing the block will not be involved in postoperative care or outcome assessment. To maintain blinding, block procedures will be performed under standardized conditions, and patients will not be informed about the specific block type administered. Outcome data will be collected by investigators who are unaware of the assigned intervention.
Intervention model description
Participants will be randomly assigned to one of two parallel groups to receive either a serratus posterior superior intercostal plane (SPSIP) block or an erector spinae plane (ESP) block for postoperative analgesia following mastectomy. The study is designed as a parallel-group trial. Randomization will be performed using a computer-generated sequence. Blinding will be maintained such that the patient, the care providers responsible for perioperative management, and the outcome assessors are unaware of group allocation. Only the anesthesiologist performing the block will be aware of the assigned intervention and will not be involved in postoperative data collection or outcome assessment.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female Gender * Mastectomy operation * 25-65 years * American Society Anestheosiology Physical Status I-III
Exclusion criteria
* American Society Anestheosiology Physical Status IV * Alcohol or substance abuse * Known allergy to local anesthetics or opioids * Severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of block application (procedure difficulty score) | Immediately after block performance | The ease of application of the block will be evaluated using a 10-point numerical rating scale (0-10), where lower scores indicate easier application and higher scores indicate greater procedural difficulty. The score will be assigned by the anesthesiologist performing the block immediately after completion of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at 24 hours | 24 hours postoperatively | Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain) at 24 hours after surgery. |
| Quality of recovery at 24 hours | 24 hours postoperatively | Postoperative recovery quality will be assessed using the Quality of recovery (QoR-15) questionnaire at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery. |
Countries
Turkey (Türkiye)
Outcome results
None listed