- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04784104
Comparison of Infraclavicular And Supraclavicular Block
Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block
연구 개요
상태
상세 설명
In this prospective single-blind study, patients will be divided into 2 groups with the closed envelope method. Patients will be taken to the block application room before the operation. Standard monitoring (pulse oximetry, noninvasive blood pressure, ECG) will be applied to the patients. Premedication will be provided with 1mg IV midazolam after peripheral vascular access. Blocks will be performed by an experienced anesthesiologist under the guidance of USG and evaluated by another anesthesiologist who is blind to the block technique. After the antisepsis of the area, a 22G 100 mm stimulator needle will be used in the infraclavicular approach and a 22G 50 mm in the supraclavicular block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine plus 5 mcg adrenaline per ml will be used as local anesthetic mixture. The infraclavicular block will be applied by the lateral sagittal method under USG guidance. Supraclavicular block will be applied in the coronal oblique plane while the probe is placed on the clavicle. Following the blocks, the 5th, 10th, 15th, 20th, 25th, and 30th-minute sensory block levels, 10th, 20th, and 30th-minute motor block levels will be recorded. Sensory block level; Axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain). The motor block will be evaluated with a modified bromage scale: 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
Block success; At the 30th minute of LA application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves. If any of these nerves are not blocked, it will be considered a failed block.
Postoperative analgesia time; It will be considered as when the NRS(Numeric Rating Scale) is≥1.
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS scores at the 2nd, 6th, 12th, 24th hours.
Sensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time. Pain score during block application will be evaluated with the NRS. Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn. Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves. Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate satisfaction, 3 = full satisfaction, after the procedure. Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome. As rescue anesthesia, sedoanalgesia will be tried with remifentanil infusion, if it is not successful, general anesthesia will be started with a laryngeal mask. As postoperative analgesic regimen, patients will receive 3 x 1000 mg IV acetaminophen. As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more. The first time when the patient receives rescue analgesia and the total dose of rescue analgesia for the first 24 hours will be recorded.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Mehmet E Şen, MD
- 전화번호: +905436838272
- 이메일: m_emre_sen@hotmail.com
연구 연락처 백업
- 이름: Zeki T Tekgül, Assoc Prof
- 전화번호: +905058554705
- 이메일: zekitekgul@yahoo.com
연구 장소
-
-
Karabağlar
-
Izmir, Karabağlar, 칠면조, 35170
- Izmir Bozyaka Training and Research Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-65 years old
- ASA I-II
- Patients scheduled for hand, wrist, and forearm surgery
Exclusion Criteria:
- Uncoordinated patients
- Having a disease that prevents sensory block evaluation,
- Have coagulopathy,
- Known allergies to drugs to be used,
- Those with anatomical disorders at the application points
- Pregnant patients,
- Patients under 18 years of age,
- Patients with known local anesthetic allergy,
- Patients diagnosed with sepsis and bacteriemia,
- Skin infection at the injection site.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Supraclaviculer block
The coronal oblique supraclavicular block will be applied to the first group with ultrasound guidance using a 22G 50 mm stimulator needle.
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine, 2 ml saline with 5 mcg adrenaline per ml.) Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
|
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
다른 이름들:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
다른 이름들:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
다른 이름들:
The blocks will be performed by an experienced anesthesiologist with a USG guidence.
|
|
실험적: Infraclaviculer block
The lateral sagittal infraclavicular block will be applied to the second group with ultrasound guidance using a 22G 100 mm stimulator needle.
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine, 2 ml saline with 5 mcg adrenaline per ml.).
Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
|
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
다른 이름들:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
다른 이름들:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
다른 이름들:
The blocks will be performed by an experienced anesthesiologist with USG guidence.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Block Formation Time
기간: 30th minute pre-operatively
|
Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves.
|
30th minute pre-operatively
|
|
Block Application Time
기간: During Block Application
|
Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn.
|
During Block Application
|
|
Block success
기간: At the 30th minute of LA application
|
Block success; at the 30th minute of local anesthesic application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves.
If any of these nerves are not blocked, it will be considered a failed block.
|
At the 30th minute of LA application
|
|
Sensory Block Level 5th minute
기간: 5th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
5th minute
|
|
Sensory Block Level 10th minute
기간: 10th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
10th minute
|
|
Sensory Block Level 15th minute
기간: 15th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
15th minute
|
|
Sensory Block Level 20th minute
기간: 20th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
20th minute
|
|
Sensory Block Level 25th minute
기간: 25th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
25th minute
|
|
Sensory Block Level 30th minute
기간: 30th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
30th minute
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Motor Block Level 10th minute
기간: 10th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
10th minute
|
|
Postoperative Analgesia Time
기간: 24 hours post-operatively
|
Postoperative analgesia time; It will be considered as when the NRS (Numeric Rating Scale) is≥1.
|
24 hours post-operatively
|
|
Pain Score Follow-up 2nd Hour
기간: 2nd hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 2nd hour.
|
2nd hour
|
|
Block Return Time
기간: 24 hours postoperatively
|
Sensory (the time from local anaesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anaesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time.
|
24 hours postoperatively
|
|
Patient and Surgeon Satisfaction
기간: Immediately after the surgery
|
Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate dissatisfaction, 3 = moderate satisfaction 4 =full satisfaction, after the procedure.
|
Immediately after the surgery
|
|
Undesirable Side Effects
기간: 24 hours postoperatively
|
Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome.
|
24 hours postoperatively
|
|
The Rescue Analgesia
기간: 24 hours postoperatively
|
As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more.
The first time when the patient receives rescue analgesia will be recorded.
|
24 hours postoperatively
|
|
24-Hour Total Opioid Consumption
기간: 24 hours postoperatively
|
The total dose of rescue analgesia (Tramadol ) for the first 24 hours will be recorded.
|
24 hours postoperatively
|
|
Pain Score Follow-up 6th Hour
기간: 6th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 6th hour.
|
6th Hour
|
|
Pain Score Follow-up 12th Hour
기간: 12th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 12th hour.
|
12th Hour
|
|
Pain Score Follow-up 24th Hour
기간: 24th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 24th hour.
|
24th Hour
|
|
The Motor Block Level 20th minute
기간: 20th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
20th minute
|
|
The Motor Block Level 30th minute
기간: 30th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
30th minute
|
공동 작업자 및 조사자
수사관
- 연구 의자: Mehmet E Şen, MD, Izmir Bozyaka Training and Research Hospital
- 연구 의자: Zeki T Tekgül, Assoc Prof, Izmir Bozyaka Training and Research Hospital
- 연구 의자: Taşkın Altay, Assoc Prof, Izmir Bozyaka Training and Research Hospital
간행물 및 유용한 링크
일반 간행물
- Gürkan Y, Hoşten T, Tekin M, Acar S, Solak M, Toker K. [Comparison of ultrasound-guided supraclavicular and infraclavicular approaches for brachial plexus blockade]. Agri. 2012;24(4):159-64. doi: 10.5505/agri.2012.38247. Turkish.
- Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
- Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
- SupraInfraTez
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
미국에서 제조되어 미국에서 수출되는 제품
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. .
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