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Postoperative Opioid Consumption of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Paravertebral Block

2026년 5월 28일 업데이트: Zagazig University

Postoperative Opioid Consumption of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Paravertebral Block After Open Thoracotomy: A Randomized Prospective Trial

Previous studies found that paravertebral and thoracic epidural continuous infusions of opioid-free local anaesthetic were found to be comparable, but paravertebral analgesia (PVA) was associated with less respiratory complications and hypotension. The newly emerging Serratus posterior superior intercostal plane block (SPSIPB) provided excellent analgesia in most studies that have focused on video-assissted thoracoscopic surgery (VATS) and breast surgery. The aim of this clinical trial is to achieve better high quality pain control with less opioid consumption either by Serratus Posterior Superior Intercostal Plane Block (SPSIPB) or Thoracic Paravertebral Block after Open thoracotomy. This study will assess and compare the analgesic efficacy of both blocks to reduce opioid consumption, the efficacy of both blocks on postoperative respiratory functions after open thoracotomy. The main question it aims to answer is:

Is there a difference between Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Thoracic Paravertebral block following open thoracotomy as regard postoperative opioid consumption, postoperative pain score, and postoperative respiratory functions? All patients will take a single dose of local anesthesia either through serratus posterior superior intercostal plane block (SPSIPB) or thoracic paravertebral block and the end of open thoracotomy then total opiod consumption willbe recorded after 24 hours postoperatively.

연구 개요

상세 설명

Prospective double-blind randomized clinical trial. All patients will be randomly allocated into two equal groups:

Group S (Serratus Posterior Superior Intercostal Plane Block group) Group P (Paravertebral Block group) Using computer generated randomization table, each group consists of 24 patients.

  • All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from all patients.
  • Age, sex, body mass index (BMI), and ASA data will be recorded. All patients in both groups will be informed about the numerical rating scale (NRS) for post-operative pain assessment prior to surgery. The NRS is a numerical scale ranging from 0 to 10, where 0-2 mean no pain, 3 mean mild pain, 4-7 mean moderate pain, 8 mean severe pain, and 9-10 mean unbearable pain.11 Also respiratory function will be assessed using spirometry and the forced expiratory volume in 1st second (FEV1).
  • All patients will be kept nil orally 8 hours before the operation except for clear fluid 2-3 hours preoperative.
  • In the operating room, standard monitors including non-invasive blood pressure (NIBP), digital pulse oximetry and electrocardiogram (ECG) will be connected to the patients, 18 G venous cannula will be inserted with ringer lactate infusion 10 ml/kg/h, also arterial cannula will be inserted for invasive blood pressure monitoring. Capnogram and temperature probe will be applied to each patient and central venous catheter will be inserted after induction of anesthesia.
  • All patients will be premedicated with 0.03mg/kg midazolam. General anesthesia will be induced by 2 µg/kg fentanyl, 1.5 mg/kg propofol and 0.6 mg/kg rocuronium will be injected i.v to facilitate tracheal intubation with a left double-lumen endotracheal tube (35-37 French) for one lung ventilation. Patients will be connected to the operating room ventilator immediately after intubation with FIO2 =1, tidal volume =6-8 ml/kg and respiratory rate to maintain Etco2= 35-40mmHg. Anesthesia will be maintained with opioid (fentanyl 1µg/kg/hr), neuromuscular blocking agent (rocuronium 0.6 mg/kg in repeated boluses), and isoflurane (minimum alveolar concentration 1-1.5).
  • At the end of the surgery, all patints will take 1 g paracetamol i.v infusion followed by 30 mg/kg ketolac i.v. Also, all patients will take 8 mg ondansteron i.v to prevent postoperative nausea and vomiting (PONV). After that, both groups will undergo regional blocks following the surgical closure and before the reversal of residual neuromuscular blockade in the lateral decubitus with the operative side up and the skin will be prepared with 10% povidone-iodine.
  • The blocks will be performed by the same anesthesiologist (performer) who is experienced by at least 20 successful uncomplicated blocks before. The post-operative assessment will be performed by a blinded second anesthesiologist (evaluator). The patient and the evaluator will be blinded to the performed block. The performer anesthesiologist may know the patients included in the block group due to the nature of the study. Both blocks will be performed by a high-frequency (7-12 MHz) linear ultrasound probe, using in-plane technique, 80 mm block needle, and 30 ml of 0.25% bupivacaine for injection.

    1. All patients will be turned into the supine position, and then neuromuscular reversal (with 4mg/kg sugammadex i.v.) and extubation will be performed in the supine position. Patients will be transferred to the recovery room and they will be assessed for pain site and pain score (NRS) at rest and during coughing. Need for analgesia will be defined as NRS ≥ 3 when 0.1 mg/kg i.v. morphine will be given as a rescue analgesia and that will be beside regular i.v. 1 g paracetamol every 8 hours from the initial intraoperative dose for all patients (as a standard analgesia with maximum dose 4 g/ 24 h). The rescue analgesic morphine dose may be repeated 10 minutes later if the pain score is still ≥ 3 with caution for avoidance of sedation or respiratory depression. The NRS will be recorded at 2, 4, 6, 12, 18, 24 hours postoperative while the patient resting (NRS static) and coughing (NRS dynamic). The 1st time for rescue analgesia, the total first 24 hours opioid consumption and its side effects such as nausea, vomiting and pruritus will be recorded. Also respiratory functions (FEV1) will be re-assessed using spirometry and recorded at the same NRS timing in the in-hospital period, and patient satisfaction at 24 hours postoperative by five-point Likert scale.

연구 유형

중재적

등록 (추정된)

48

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Sharqia Province
      • Zagazig, Sharqia Province, 이집트
        • Zagazig university hospitals

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

설명

Inclusion Criteria:

  • BMI (25-35kg/m²).
  • Physical status: ASA I-II - III.
  • Patients undergoing posterolateral thoracotomy for lung resection.

Exclusion Criteria:

  • Emergency surgeries.
  • Uncooperative patient.
  • History of allergy to study drugs.
  • Patients with coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders (e.g. Alzheimer, Dementia, Delirium, mental retardation and cognitive dysfunction).
  • Infection at the site of block .

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Group S (Serratus Posterior Superior Intercostal Plane Block group)
patients will receive ultrasound-guided serratus posterior superior intercostal plane block
As described by Tulger et al., the block will be performed by a high-frequency (7-12 MHz) linear ultrasound probe. After slight scapular lateral displacement, the probe will be placed transversely at the level of the scapular spine. The upper border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), and 2nd and 3rd ribs will be visualized. Using in-plane technique, the 80 mm block needle will be introduced from the level of the 3rd rib in the caudocranial direction through the medial scapular border passes through the skin and subcutaneous tissue to target the 3rd rib. After negative aspiration, the needle tip will be placed between the 3rd rib and the SPSM, hydro-dissection using 1-2 ml saline to ensure the correct needle placement then 30 ml of 0.25% bupivacaine will be injected between the SPSM and the 3rd rib.
활성 비교기: Group P (Paravertebral Block group)
patients will receive ultrasound guided thoracic paravertebral nerve block
A high-frequency (7-12 MHz) linear ultrasound probe will be placed 2-3cm lateral to the upper edge of the spinous process of the 5th thoracic vertebrae body which identified by counting down from the seventh cervical vertebrae. After visualizing the transverse process, the underlying muscles, the paravertebral space, the internal intercostal membrane, and the pleura, 80 mm block needle will be inroduced by the in-plane technique till the paravertebral space over the superior border of the transverse process. After identification of the paravertebral space using a loss of resistance technique, 30 ml of 0.25% bupivacaine will be injected.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total opioid consumption
기간: up to 24 hours postoperative
Total first 24 hours opioid consumption
up to 24 hours postoperative

2차 결과 측정

결과 측정
측정값 설명
기간
Time of the block performance
기간: perioperative
time from ultrasound probe placement on patient's skin till the local anesthetic injection
perioperative
1st time for rescue analgesia
기간: perioperative
time from patient's recovery till numerical rating scale (NRS) ≥ 3
perioperative
Postoperative pain score
기간: 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperative
The numerical rating scale (NRS) for post-operative pain assessment prior to surgery. The NRS is a numerical scale ranging from 0 to 10, where 0-2 mean no pain, 3 mean mild pain, 4-7 mean moderate pain, 8 mean severe pain, and 9-10 mean unbearable pain.
2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperative
Forced expiratory volume in 1 second (FEV1)
기간: baseline, 2 hours, 4 hours, 6 hours, 12, hours, 18 hours, 24 hours postoperative
measuring the maximum amount of air patient can exhale in one second
baseline, 2 hours, 4 hours, 6 hours, 12, hours, 18 hours, 24 hours postoperative
Patient satisfaction
기간: 24 hours postoperative
Patient satisfaction at 24 hours postoperative by five-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied
24 hours postoperative

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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)

2026년 5월 15일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2026년 12월 15일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

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Serratus Posterior Superior Intercostal Plane Block (single injection)에 대한 임상 시험

구독하다