Breast Cancer, Postoperative Pain
Conditions
Keywords
Breast Neoplasms, Postoperative Pain, Anesthesia, Conduction
Brief summary
This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.
Detailed description
Breast cancer surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia strategies for breast surgery. The rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block are recently described regional anesthesia techniques that may provide effective postoperative analgesia by blocking the lateral and posterior branches of the thoracic spinal nerves. However, comparative clinical evidence regarding their analgesic efficacy and dermatomal coverage in modified radical mastectomy remains limited. This prospective randomized double-blind controlled trial will compare RISS block and SPSIP block in adult patients undergoing modified radical mastectomy under general anesthesia. Participants will be randomly allocated to receive either RISS block or SPSIP block before surgery. The primary objective is to compare postoperative opioid consumption. Secondary outcomes include postoperative pain scores, dermatomal sensory spread, time to first rescue analgesia, quality of recovery, opioid-related adverse events, and block-related complications.
Interventions
Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia.
PROCEDURESerratus Posterior Superior Intercostal Plane Block
Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia.
Sponsors
Ferit Yetik
Bursa City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either a Rhomboid Intercostal-Subserratus Plane (RISS) block or a Serratus Posterior Superior Intercostal Plane (SPSIP) block before modified radical mastectomy. Outcomes will be compared between two parallel groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-75 years * ASA physical status I-III * Scheduled for elective unilateral modified radical mastectomy with axillary dissection under general anesthesia * Provision of written informed consent
Exclusion criteria
* Anticoagulant therapy * Bleeding diathesis * Known allergy to local anesthetics or opioids * Infection at the block application site or previous surgery in the block area * Cognitive impairment preventing NRS assessment * Pregnancy or lactation * Chronic opioid use * Severe hepatic or renal failure * Refusal to participate in the study * Technical inability to perform the block or failed block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Opioid Consumption | 24 hours after surgery | Total opioid consumption during the first 24 hours after modified radical mastectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | 0-24 hours after surgery | Postoperative pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. |
| Compartmental Pain Scores Using Numeric Rating Scale | 0-24 hours after surgery | Numeric Rating Scale (NRS) score (0-10 points) measured separately for axillary pain, anterolateral chest wall pain, and surgical drain insertion site pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| Dermatomal Sensory Block Distribution | 30 minutes after block performance | Number of dermatomes blocked, assessed by pinprick sensory testing 30 minutes after block performance. Higher values indicate wider sensory block distribution. |
| Quality of Recovery-15 Score | 24 hours after surgery | Quality of Recovery-15 (QoR-15) questionnaire score ranging from 0 to 150, where higher scores indicate better postoperative recovery and patient satisfaction. |
| Intraoperative Remifentanil Consumption | During surgery | Total intraoperative remifentanil consumption will be recorded and compared between groups. |
| Block- and Opioid-Related Complications | 24 hours after surgery | Complications related to block performance and opioid use will be recorded. |
Countries
Turkey (Türkiye)
Contacts
CONTACTYusuf Alan, MD
PRINCIPAL_INVESTIGATORMürsel Ekinci, MD
Bursa City Hospital
STUDY_CHAIRYusuf Alan, MD
Bursa City Hospital
Outcome results
None listed