- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07586670
Comparison of 90° and 120° Arm Positions in Costoclavicular Block (COSTO-RCT)
Effect of Arm Abduction Degree ( 90° vs. 120° ) on Block Onset Time and Block Success in Costoclavicular Brachial Plexus Block in Patients Undergoing Hand, Wrist and Forearm Surgery: A Prospective Randomized Controlled Trial
The costoclavicular approach of the infraclavicular brachial plexus block is widely used for upper extremity surgeries due to its reliable anatomy and high success rates. Patient positioning, particularly the degree of arm abduction, may influence the spread of local anesthetic and the characteristics of the block. However, the optimal arm abduction angle during this procedure remains unclear.
This prospective randomized controlled trial aims to investigate the effect of two different arm abduction angles (90° and 120°) on block onset time and block success in patients undergoing hand, wrist, and forearm surgery under ultrasound-guided costoclavicular brachial plexus block.
Patients will be randomly assigned to one of two groups according to the degree of arm abduction. The primary outcome is block onset time. Secondary outcomes include block success, sensory and motor block characteristics, perfusion index changes, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia, postoperative neurological evaluation at 4 and 24 hours, complications, and patient satisfaction.
The findings of this study are expected to provide evidence on optimal patient positioning to improve the effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.
연구 개요
상세 설명
The costoclavicular approach is a recently described infraclavicular technique for brachial plexus block that provides reliable anesthesia for upper extremity surgeries. Due to the compact arrangement of the cords in the costoclavicular space, this technique has gained popularity for its high success rates and consistent anatomy. However, procedural factors such as patient positioning may influence the distribution of local anesthetic and the effectiveness of the block.
Arm abduction is known to alter the anatomical relationships within the infraclavicular region, potentially affecting needle visualization, spread of local anesthetic, and block characteristics. Despite its clinical relevance, there is limited evidence regarding the optimal degree of arm abduction during ultrasound-guided costoclavicular brachial plexus block.
This prospective randomized controlled study aims to compare two different arm abduction angles 90° and 120° in patients undergoing elective hand, wrist, and forearm surgery. After obtaining written informed consent, eligible patients will be randomly assigned into two groups according to the degree of arm abduction.
All procedures will be performed under ultrasound guidance using a standardized technique. The local anesthetic will be administered in the costoclavicular space, and block characteristics will be assessed systematically. The primary outcome is block onset time, defined as the time from completion of local anesthetic injection to the achievement of adequate sensory block for surgery.
Secondary outcomes include block success, sensory and motor block scores, perfusion index measurements, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia or conversion to general anesthesia, early complications, postoperative neurological evaluation at 4 and 24 hours, and patient satisfaction assessed using a Likert scale.
The results of this study are expected to provide valuable evidence regarding optimal patient positioning and contribute to improving the clinical effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Algan TURGUT ÇARSANCAKLI, M.D.
- 전화번호: +90 532 486 52 69
- 이메일: alganturgut@gmail.com
연구 연락처 백업
- 이름: Reyhan POLAT, Professor
- 전화번호: +90 532 673 43 10
- 이메일: reyhanp9@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged between 18 and 80 years.
- Patients scheduled for elective upper extremity surgery (hand, wrist, forearm).
- Patients classified as ASA I-III.
- Patients who provide informed consent after being informed about the study.
Exclusion Criteria:
- History of previous surgery, scar tissue, tumor, or trauma that may alter brachial plexus anatomy.
- Presence of infection, hematoma, severe edema, burn, or open wound at the block application site.
- Known allergy to local anesthetics or other medications used in the study.
- Coagulopathy, use of anticoagulants, or platelet count < 100,000/mm³.
- History of peripheral neuropathy, neurological deficit, cervical radiculopathy, or CRPS.
- Pregnancy or breastfeeding.
- Patients with BMI < 18 kg/m².
- Patients with BMI > 35 kg/m².
- Severe cardiac, pulmonary, renal, or hepatic failure.
- Mental retardation, communication difficulties, or lack of cooperation.
- Deformity, amputation, or large mass in the surgical extremity that may interfere with sensorimotor assessment.
- Preoperative significant sensory loss, motor weakness, or signs of neurological disease.
- Severe anemia (Hb < 9 g/dL) or polycythemia (Hb > 18 g/dL).
- Psychiatric disorders, substance abuse, or any condition that may interfere with study compliance.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 90° Arm Abduction
Patients receive ultrasound-guided costoclavicular brachial plexus block with the arm positioned at 90° abduction.
|
Ultra-sound Guided costoclavicular brachial plexus block performed for upper extremity surgery using a standard local anesthetic technique
|
|
실험적: 120° Arm Abduction
Patients receive ultrasound-guided costoclavicular brachial plexus block with the arm positioned at 120° abduction.
|
Ultra-sound Guided costoclavicular brachial plexus block performed for upper extremity surgery using a standard local anesthetic technique
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Block Onset Time
기간: Up to 30 minutes after block performance
|
Time from completion of local anesthetic injection to achievement of adequate sensory block sufficient for surgery, assessed by pinprick test.
|
Up to 30 minutes after block performance
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Block Success
기간: İntraoperative period
|
Successful completion of surgery without the need for additional anesthesia.
|
İntraoperative period
|
|
Sensory Block Score
기간: Baseline and at 5-minute intervals up to 20 minutes after block performance.
|
Sensory block was assessed using a 3-point pinprick scale ( 0= normal sensation, 1= loss of pinprick sensation, 2= complete sensory block).
|
Baseline and at 5-minute intervals up to 20 minutes after block performance.
|
|
Motor Block Score
기간: Baseline and at 5-minute intervals up to 30 minutes after block performance.
|
Motor block was assessed using a 3-point motor scale (0= normal motor function, 1= reduced motor strength, 20 complete motor block).
|
Baseline and at 5-minute intervals up to 30 minutes after block performance.
|
|
Perfusion Index
기간: Baseline and at 5,10,15 and 20 minutes after block performance.
|
Perfusion index values measured using a Masimo pulse oximeter probe placed on the blocked upper extremity.
|
Baseline and at 5,10,15 and 20 minutes after block performance.
|
|
Readiness for Surgery
기간: 15 minutes after block
|
Proportion of patients ready for surgery at 15 and 20 minutes.
|
15 minutes after block
|
|
Readiness for Surgery
기간: 20 minutes after block
|
Proportion of patients ready for surgery at 15 and 20 minutes
|
20 minutes after block
|
|
Block Performance Time
기간: During procedure ( min )
|
Time required to perform the block.
|
During procedure ( min )
|
|
Need for Additional Anesthesia
기간: Intraoperative period
|
Requirement for supplemental anesthesia or conversion to general anesthesia.
|
Intraoperative period
|
|
Complications
기간: Up to 24 hours
|
Early complications related to block
|
Up to 24 hours
|
|
Postoperative Sensory and Motor Function Assessment
기간: 4 hours after surgery
|
Postoperative neurological evaluation including sensory and motor function examination of the blocked upper extremity to assess for neurological complications.
|
4 hours after surgery
|
|
Postoperative Sensory and Motor Function Assessment
기간: 24 hours after surgery
|
Postoperative neurological evaluation including sensory and motor function examination of the blocked upper extremity to assess for neurological complications.
|
24 hours after surgery
|
|
Patient Satisfaction
기간: At the end of the surgery and 24 hours postoperatively
|
Patient satisfaction assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
|
At the end of the surgery and 24 hours postoperatively
|
|
Hemodynamic Parametres
기간: Baseline and at 5,10,15 and 20minutes after block performance
|
Heart rate
|
Baseline and at 5,10,15 and 20minutes after block performance
|
|
Systolic Blood Pressure
기간: Baseline and at 5,10,15 and 20 minutes after block performance.
|
Systolic blood pressure values measured during and after block performance.
|
Baseline and at 5,10,15 and 20 minutes after block performance.
|
|
Diastolic Blood Pressure
기간: Baseline and at 5,10,15 and 20 minutes after block performance.
|
Diastolic blood pressure values measured during and after block performance.
|
Baseline and at 5,10,15 and 20 minutes after block performance.
|
|
Mean Arterial Pressure
기간: Baseline and at 5,10,15 and 20 minutes after block performance.
|
Mean arterial pressure values measured during and after block performance.
|
Baseline and at 5,10,15 and 20 minutes after block performance.
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Reyhan Polat, Professor, Ankara Etlik City Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
- AEŞH-EK-2026-07
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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