Aydın Adnan Menderes University Hospital, Department of Anesthesiology and Reanimation
Aydin, Aydın, 09010, Turkey (Türkiye)
NCT Number: NCT07229092
This prospective, randomized clinical study aims to compare the analgesic efficacy of serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) for postoperative analgesia in patients undergoing elective bilateral breast reduction surgery under general anesthesia. All patients will receive standardized general anesthesia. Before induction of anesthesia, while patients are awake, Group SPB will receive an ultrasound-guided serratus anterior plane block and Group RIPB will receive an ultrasound-guided rhomboid intercostal plane block. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (PCA) with opioids. Primary outcomes include postoperative pain scores and opioid consumption at 1, 6, 12, and 24 hours. Secondary outcomes include time to first analgesic demand, patient satisfaction, and block-related complications.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
Female
Interventional
Not applicable
Aydin, Aydın, 09010, Turkey (Türkiye)
Postoperative pain management in breast reduction surgery is challenging due to wide tissue dissection and thoracic wall involvement. Serratus plane block (SPB) and rhomboid intercostal plane block (RIPB) are regional anesthesia techniques that provide analgesia by blocking the lateral cutaneous branches of the intercostal nerves.
This randomized controlled trial will compare the analgesic efficacy of SPB and RIPB in female patients aged 18-65 undergoing elective bilateral breast reduction surgery under general anesthesia.
Before induction of general anesthesia, while patients are awake, ultrasound-guided SPB or RIPB will be performed according to group allocation. After block performance, general anesthesia will be induced using a standardized protocol. Postoperative pain management will be provided with intravenous patient-controlled analgesia (PCA) with opioids.
Primary outcomes include postoperative pain scores (NRS) and opioid consumption. Secondary outcomes include duration of analgesia, time to first analgesic request, patient satisfaction, and block-related complications. The hypothesis is that both blocks will reduce postoperative pain and opioid consumption, but the duration and quality of analgesia may differ between SPB and RIPB.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
American Society of Anesthesiologists (ASA) physical status I-II
Scheduled for elective bilateral breast reduction surgery under general anesthesia
Willing and able to provide written informed consent
Exclusion criteria
Coagulopathy or anticoagulant medication use
Infection at or near the injection site
History of chronic opioid use or psychiatric/neurological disorders affecting pain perception
Body mass index (BMI) > 35 kg/m²
Refusal to participate in the study
"Ultrasound-guided serratus anterior plane block performed preoperatively while patients are awake. A total of 30 mL of local anesthetic solution (5 mL saline, 5 mL of 2% lidocaine, 20 mL of 0.25% bupivacaine) will be used. The total volume will be divided equally between both breasts (15 mL per side), with one injection point on each side at the midaxillary line
Ultrasound-guided rhomboid intercostal plane block (RIPB) performed preoperatively while patients are awake, using a total of 30 mL local anesthetic solution (5 mL normal saline, 5 mL of 2% lidocaine, and 20 mL of 0.25% bupivacaine). The total volume will be divided equally between both breasts (15 mL per side), with one injection point on each side between the rhomboid major muscle and the intercostal muscles at the medial border of the scapula around the 5th intercostal level.
Participants in this group will not receive any regional block. Standard general anesthesia and multimodal postoperative analgesia will be provided according to institutional protocol.
Time frame: 24 hours after surgery
Total opioid consumption will be recorded using intravenous patient-controlled analgesia (PCA) during the first 24 hours after surgery. The cumulative tramadol dose (mg) administered via PCA will be calculated based on the number of patient-controlled bolus doses.
Time frame: 1, 6, 12, and 24 hours after surgery
Pain intensity will be assessed using the Numeric Rating Scale (NRS), a 0-10 point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at rest and during movement at 1, 6, 12, and 24 hours after surgery
Konul Karaja
Other
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Reduction Surgery: A Randomized Clinical Study
Acronym: SAPB-RIPB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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