SPSIP Block for Pain Control After Breast Reduction Surgery (SPSIP-RM)
Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery.
The main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block.
Participants will:
- Have planned bilateral breast reduction surgery under general anesthesia
- Be randomly assigned to the SPSIP block group or the control group
- Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery
- Have their pain score and pain medicine use recorded during the first 24 hours after surgery
- Be followed for safety and complications for 30 days after surgery
연구 개요
상태
상세 설명
Reduction mammaplasty, also known as breast reduction surgery, may be associated with early postoperative pain because it is usually performed bilaterally and involves wide surgical dissection and tissue resection. Multimodal pain treatment is commonly used after this procedure to provide adequate pain control and to limit opioid exposure.
The serratus posterior superior intercostal plane block (SPSIP block) is an ultrasound-guided fascial plane block used for thoracic wall analgesia. Recent studies have evaluated this block in breast surgery, but data specific to reduction mammaplasty remain limited. In routine practice, surgical local anesthetic infiltration is often used during reduction mammaplasty. Therefore, this trial will evaluate whether adding bilateral SPSIP block to standard anesthesia, surgical local infiltration, and standard postoperative pain treatment provides additional opioid-sparing benefit.
This study is designed as a prospective, randomized, parallel-group, assessor-blinded, single-center clinical trial. Participants scheduled for elective bilateral reduction mammaplasty will be assigned in a 1:1 ratio to either the SPSIP block group or the control group. In the SPSIP block group, bilateral SPSIP block will be performed under ultrasound guidance after induction of general anesthesia and before surgical local infiltration and skin incision. The control group will not receive SPSIP block.
Both groups will receive the same standardized general anesthesia, surgical local anesthetic infiltration, postoperative multimodal analgesia, and rescue analgesia protocol. The local anesthetic agent, concentration, volume, and maximum safe dose limits for the block and surgical infiltration will be standardized before study enrollment.
The trial is planned to reflect routine plastic surgery practice. Surgical technique, pedicle selection, resection amount, drain use, and the use of dermal graft or internal support when clinically needed will be decided by the surgical team according to participant anatomy and routine clinical judgment. These variables will be recorded to describe surgical variability and may be considered in additional analyses if needed.
Postoperative pain assessments will be performed by ward nurses who are blinded to group allocation. Opioid use will be obtained from medication administration records. Block-related events and surgical complications will be recorded during routine postoperative care and up to 30 days after surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Murat Çelik, Assistant Professor
- 전화번호: +905546902104
- 이메일: mucetr@gmail.com
연구 연락처 백업
- 이름: Handan Derebaşınlıoğlu, Associate Professor
- 전화번호: (0346) 258 00 00
- 이메일: hastane@cumhuriyet.edu.tr
연구 장소
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Sivas
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Sivas, Sivas, 터키 (Türkiye), 58050
- 모병
- Sivas Cumhuriyet University
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수석 연구원:
- Murat Çelik, Assistant Professor
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부수사관:
- Handan Derebaşınlıoğlu, Associate Professor
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연락하다:
- Murat Çelik
- 전화번호: 05546902104
- 이메일: mucetr@gmail.com
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연락하다:
- Onur Avcı, Associate Professor
- 전화번호: 90 530 112 64 08
- 이메일: dronuravci@gmail.com
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부수사관:
- Onur Avcı, Associate Professor
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Female participants aged 18 to 65 years
- Scheduled for elective bilateral reduction mammaplasty
- Planned surgery under general anesthesia
- American Society of Anesthesiologists physical status class I to III
- Planned postoperative clinical follow-up for the first 24 hours after surgery
- Able to understand and report pain using the 0 to 10 Numeric Rating Scale
- Able to provide written informed consent for study participation
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetic drugs
- Contraindication to regional anesthesia or fascial plane block
- Coagulopathy or clinically significant bleeding disorder
- Use of anticoagulant or antiplatelet medication that prevents safe block application
- Infection at the planned block injection site
- Chronic opioid use, chronic pain syndrome, or regular analgesic use that may affect postoperative pain assessment
- Revision breast surgery
- Planned major additional surgical procedure other than reduction mammaplasty
- Pregnancy or lactation
- Unable to reliably report pain scores
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: SPSIP Block Group
Participants in this arm will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block after induction of general anesthesia and before surgical local infiltration and skin incision.
They will also receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment.
|
Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed after induction of general anesthesia and before surgical local anesthetic infiltration and skin incision.
다른 이름들:
Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
다른 이름들:
|
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활성 비교기: Control Group
Participants in this arm will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment.
They will not receive serratus posterior superior intercostal plane block.
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Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Opioid Consumption During the First 24 Hours After Surgery
기간: From the end of surgery to 24 hours after surgery
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Total opioid consumption will be calculated from all rescue opioid analgesics administered during the first 24 hours after surgery.
Opioid use will be obtained from medication administration records and reported as intravenous morphine equivalent dose in milligrams.
Higher values indicate greater opioid consumption.
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From the end of surgery to 24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Resting Pain Score at 6 Hours After Surgery
기간: 6 hours after surgery
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Pain intensity at rest will be assessed using the 0 to 10 Numeric Rating Scale.
A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain.
Higher scores indicate greater pain intensity.
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6 hours after surgery
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Time to First Rescue Analgesic Requirement
기간: From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
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The time from the end of surgery to the first administration of rescue analgesic medication will be recorded.
Longer time indicates longer duration before additional analgesic treatment is needed.
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From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
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Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours
기간: From the end of surgery to 24 hours after surgery
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The number of participants who develop postoperative nausea, vomiting, or require additional antiemetic medication during the first 24 hours after surgery will be recorded.
This outcome will be assessed as present or absent for each participant.
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From the end of surgery to 24 hours after surgery
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공동 작업자 및 조사자
수사관
- 연구 책임자: Handan Derebaşınlıoğlu, Associate Professor, Cumhuriyet University
간행물 및 유용한 링크
일반 간행물
- Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Gundogdu O, Avci O, Balci F, Tekcan MN, Kol YC. Efficacy of Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: An Evidence Based Report. J Coll Physicians Surg Pak. 2024 Mar;34(3):348-350. doi: 10.29271/jcpsp.2024.03.348.
- Singh NP, Makkar JK, Kuberan A, Guffey R, Uppal V. Efficacy of regional anesthesia techniques for postoperative analgesia in patients undergoing major oncologic breast surgeries: a systematic review and network meta-analysis of randomized controlled trials. Can J Anaesth. 2022 Apr;69(4):527-549. doi: 10.1007/s12630-021-02183-z. Epub 2022 Jan 31.
- Chadbourne EB, Zhang S, Gordon MJ, Ro EY, Ross SD, Schnur PL, Schneider-Redden PR. Clinical outcomes in reduction mammaplasty: a systematic review and meta-analysis of published studies. Mayo Clin Proc. 2001 May;76(5):503-10. doi: 10.4065/76.5.503.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26_06_04_35
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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