- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07739303
Anterior Suprascapular and Axillary vs. Interscalene Block for Analgesia and Diaphragmatic Function in Shoulder Surgery
Comparison of Anterior Suprascapular and Axillary Nerve Block Versus Interscalene Block for Postoperative Analgesia and Diaphragmatic Function in Shoulder Surgery: A Randomized Controlled Trial
Shoulder surgeries are among the most frequently performed orthopedic interventions and are often associated with moderate to severe postoperative pain. In these procedures, effective pain management is crucial for early rehabilitation and patient comfort.
Peripheral nerve blockade is widely used for postoperative analgesia in shoulder surgery. While the interscalene brachial plexus block is considered the gold standard for pain control, it is frequently associated with unintended phrenic nerve blockade, leading to hemidiaphragmatic paresis. To minimize respiratory complications while maintaining effective analgesia, alternative diaphragm-sparing regional anesthesia techniques, such as the combination of suprascapular and axillary nerve blocks, have been introduced.
The aim of this study is to compare the analgesic efficacy and respiratory functions preservation of the ultrasound-guided anterior approach suprascapular combined with axillary nerve block versus interscalene block in patients undergoing shoulder surgery
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: İbrahim Topcu
- 전화번호: +905437860316
- 이메일: ibrahimtpc78@gmail.com
연구 연락처 백업
- 이름: Musa Zengin
- 전화번호: +905307716235
- 이메일: musazengin@gmail.com
연구 장소
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Ankara
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Yenimahalle, Ankara, 터키 (Türkiye), 06170
- 모병
- Ankara Etlik City Hospital
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연락하다:
- İbrahim Topcu
- 전화번호: +905437860316
- 이메일: ibrahimtpc78@gmail.com
-
연락하다:
- Musa Zengin
- 전화번호: +905307716235
- 이메일: musazengin@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Patients scheduled to undergo elective arthroscopic shoulder surgery
- BMI between 18 and 30 kg/m2
- Ability to provide written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetics
- Presence of localized infection at the planned injection site
- Severe coagulopathy or active use of anticoagulant medications
- Contralateral phrenic nerve palsy or a diagnosis of severe chronic obstructive pulmonary disease (COPD)
- History of chronic opioid consumption or neuropathic pain
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Interscalene Block
After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely at the level of the cricoid cartilage (C6) with the head turned to the contralateral side.
Advancing the needle laterally into the interscalene groove between the anterior and middle scalene muscles, 10 mL of local anesthetic (%0.5 bupivacaine ) will be injected between the C5 and C6 nerve roots.
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Interscalene block will be performed on the patients using 10 mL of 0.5% bupivacaine under ultrasound guidance.
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활성 비교기: Combination of Axillary and Anterior Suprascapular Blocks
After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely in the supraclavicular fossa with the head turned to the contralateral side.
Advancing the needle in-plane, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the suprascapular nerve as it branches anteriorly from the superior trunk of the brachial plexus.
Subsequently, for the axillary nerve block, the patient will be positioned laterally and the ultrasound probe will be placed longitudinally over the posterior aspect of the shoulder.
Advancing the needle into the quadrangular space, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the axillary nerve adjacent to the posterior circumflex humeral artery.
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Combined anterior suprascapular(5 ml) and axillary nerve blocks(5 ml) will be performed on the patients using a total of 10 mL of 0.5% bupivacaine under ultrasound guidance.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Intensity at Rest
기간: 4 hours after surgery.
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Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest.
Pain assessment at rest will be made at 4 hours after surgery.
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4 hours after surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Intensity at Rest
기간: Up to 24 hours
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Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest.
Pain assessment at rest will be made at 1, 8, 12, and 24 hours after surgery.
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Up to 24 hours
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Postoperative Pain Intensity at Movement
기간: Up to 24 hours
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Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at movement.
Pain assessment at rest will be made at 1, 4, 8, 12, and 24 hours after surgery.
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Up to 24 hours
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Total Postoperative Opioid Consumption
기간: Up to 24 hours
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The total amount of opioid consumed by the patient will be recorded.
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Up to 24 hours
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Area Under Curve
기간: At the 24th hour
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Cumulative 24-hour pain burden calculated by the trapezoidal rule
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At the 24th hour
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Diaphragmatic Excursion
기간: Baseline (immediately before block performance) and 30 minutes after block performance
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Diaphragmatic excursion will be measured in centimeters (cm) using M-mode ultrasonography during normal breathing and deep breathing (sniff test).
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Baseline (immediately before block performance) and 30 minutes after block performance
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Forced vital capacity (FVC) (volume)
기간: Perioperative period
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Forced vital capacity (FVC) (volume) will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1 and 24 hours.
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Perioperative period
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Forced expiratory flow in 1 s (FEV1) (volume)
기간: Perioperative period
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Forced expiratory flow in 1 s (FEV1) (volume) will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1 and 24 hours.
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Perioperative period
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FEV1/FVC
기간: Perioperative period
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FEV1/FVC will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1 and 24 hours.
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Perioperative period
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공동 작업자 및 조사자
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .