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Diaphragmatic Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block (ICB-SNB)

2026년 6월 5일 업데이트: Ceren Gul AKPINAR, Gazi University

Evaluation of the Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block on the Diaphragm in Arthroscopic Shoulder Surgery

This prospective observational study was conducted to evaluate the effects of a combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic function in patients undergoing arthroscopic shoulder surgery. A total of 61 adult patients were enrolled in the study. Diaphragmatic excursion was assessed using ultrasonography both prior to block administration and 30 minutes following the procedure during normal and deep breathing. The primary objective was to assess changes in diaphragmatic excursion and determine the incidence of hemidiaphragmatic paralysis associated with this combined block technique. Secondary outcomes included block performance time, duration of postoperative analgesia, the need for additional intraoperative sedation or analgesia, the occurrence of adverse events, and levels of patient and surgeon satisfaction. The study sought to determine whether this regional anesthesia approach could provide effective anesthesia and analgesia while minimizing impairment of diaphragmatic function.

연구 개요

상세 설명

This prospective observational study was conducted to evaluate the effects of combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic excursion in patients undergoing elective arthroscopic shoulder surgery.

Patients scheduled for arthroscopic shoulder surgery under regional anesthesia were enrolled in the study. Prior to block administration, baseline diaphragmatic excursion was assessed using ultrasonography during both normal and deep breathing. Each measurement was repeated three times, and the mean value was recorded. The same measurements were repeated 30 minutes after completion of the block procedures using an identical protocol.

The percentage change in diaphragmatic excursion between baseline and post-block measurements was calculated for both normal and deep breathing. Hemidiaphragmatic paralysis was categorized according to the degree of reduction in diaphragmatic excursion as absent (≤25% reduction), partial (25.1-74.9% reduction), or complete (≥75% reduction).

All nerve blocks were performed under ultrasound guidance by anesthesiologists experienced in regional anesthesia techniques. The infraclavicular brachial plexus block was performed using 15 mL of 0.5% bupivacaine deposited around the posterior cord and 8 mL of 0.5% bupivacaine around the lateral cord. The anterior suprascapular nerve block was performed with 7 mL of 0.5% bupivacaine. In addition, arthroscopic portal sites were infiltrated with 10 mL of 0.2% bupivacaine to provide supplementary analgesia.

All patients received intravenous midazolam (2 mg) and paracetamol (1 g) during the intraoperative period. Additional analgesic or sedative medication was administered when required according to clinical conditions and surgical needs. Block performance time, requirement for supplemental analgesia or sedation, and any block-related adverse events were recorded.

The primary outcome measure was the change in diaphragmatic excursion measured by ultrasonography 30 minutes after block administration. Secondary outcome measures included the incidence and severity of hemidiaphragmatic paralysis, block performance time, duration of postoperative analgesia, need for additional intraoperative analgesia or sedation, time to first analgesic requirement, patient and surgeon satisfaction, block-related complications, and conversion to general anesthesia.

The study was designed to investigate whether the combination of infraclavicular brachial plexus block and anterior suprascapular nerve block could provide effective anesthesia and analgesia for arthroscopic shoulder surgery while minimizing impairment of diaphragmatic function and reducing the incidence of clinically significant hemidiaphragmatic paralysis.

연구 유형

관찰

등록 (실제)

61

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Ankara
      • Ankara, Ankara, 터키 (Türkiye), 06500
        • Gazi University Faculty of Medicine Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Adult patients aged 18-80 years with ASA physical status I-III undergoing elective arthroscopic shoulder surgery at Gazi University Faculty of Medicine Hospital. Eligible participants received ultrasound-guided combined infraclavicular brachial plexus block and anterior suprascapular nerve block. The study evaluated changes in diaphragmatic excursion measured by ultrasonography before and after block administration.

설명

Inclusion Criteria:

  • Patients aged 18-80 years.
  • ASA physical status I-III.
  • Scheduled for elective arthroscopic shoulder surgery.
  • Ability to provide written informed consent

Exclusion Criteria:

  • Refusal to undergo peripheral nerve block.
  • Pre-existing peripheral neuropathy.
  • Known pulmonary, hepatic, or renal disease.
  • Allergy to local anesthetics.
  • Infection at the block site.
  • Pre-existing neurological deficit.
  • Body mass index (BMI) > 40 kg/m².
  • Coagulopathy.
  • Sepsis.
  • Previous surgery at the planned block site.

    • Major psychiatric disorders.
    • Inability to complete diaphragmatic ultrasonographic assessment.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Patients Undergoing Arthroscopic Shoulder Surgery
Patients undergoing arthroscopic shoulder surgery who received a combined infraclavicular brachial plexus block and anterior suprascapular nerve block. Diaphragmatic excursion was evaluated using ultrasonography before and after block administration.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Diaphragmatic Excursion at 30 Minutes After Block Administration
기간: 30 minutes after block administration
Diaphragmatic excursion measured by ultrasonography during normal and deep breathing before block administration and 30 minutes after block administration. The percentage change from baseline was calculated.
30 minutes after block administration

2차 결과 측정

결과 측정
측정값 설명
기간
Incidence of Hemidiaphragmatic Paralysis
기간: 30 minutes after block administration
Presence of hemidiaphragmatic paralysis determined by ultrasonographic assessment of diaphragmatic excursion.
30 minutes after block administration
Degree of Hemidiaphragmatic Paralysis
기간: 30 minutes after block administration
Hemidiaphragmatic paralysis classified as absent (≤25% reduction), partial (25.1-74.9% reduction), or complete (≥75% reduction)
30 minutes after block administration
Block Performance Time
기간: From needle insertion to completion of the block procedure
Time required to complete the combined infraclavicular brachial plexus block and anterior suprascapular nerve block.
From needle insertion to completion of the block procedure
Additional Intraoperative Analgesia Requirement
기간: From surgical incision to the end of surgery
Requirement for supplemental analgesic medication during surgery.
From surgical incision to the end of surgery
Time to First Analgesic Requirement
기간: Up to 24 hours after surgery
Time from completion of the block procedure to the first postoperative analgesic request.
Up to 24 hours after surgery
Block-Related Complications
기간: From block administration until 24 hours after surgery
Incidence of block-related adverse events including Horner syndrome, hoarseness, nausea/vomiting, and hemodynamic complications.
From block administration until 24 hours after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: IRFAN GUNGOR, MD, Gazi University Faculty of Medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 22일

기본 완료 (실제)

2025년 7월 20일

연구 완료 (실제)

2025년 7월 20일

연구 등록 날짜

최초 제출

2026년 5월 31일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 5일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data collected during the study will not be shared with other researchers because of institutional policies, ethical considerations, and protection of participant confidentiality.

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미국 FDA 규제 기기 제품 연구

아니

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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