Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-29 @ 3:35 AM
Study NCT ID:
NCT07229092
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Breast Reduction Surgery
Sponsor:
Konul Karaja
Organization:
Study Overview
Official Title:
Comparison of Serratus Plane Block and Rhomboid Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Reduction Surgery: A Randomized Clinical Study
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAPB-RIPB
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: