- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07591129
Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block After Laparoscopic Sleeve Gastrectomy
Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Controlled Trial
연구 개요
상태
상세 설명
Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and Subcostal Transversus Abdominis Plane Block (TAPB) on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic sleeve gastrectomy. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) >35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.
Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group TAPB will receive a bilateral subcostal TAP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.
ITP Block :
Intertransverse Process Block (ITP) will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae.
Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.
Subcostal TAP Block:
The Subcostal Transversus Abdominis Plane Block (TAPB) will be performed 30 minutes prior to surgery with the patient in a supine position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned parallel to the lower costal margin.
Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle.. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.
General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey). Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.
Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 4 mg intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU). Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.
Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively.
All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours.
Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.
Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.
Patient Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.
Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:
0 = none
- = mild
- = moderate
- = severe
Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: MUSTAFA KILIN, CONSULTANT İN ANESTHESİOLOGY
- 전화번호: +905464569218
- 이메일: mustafa.kilin90@gmail.com
연구 장소
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Antalya, 터키 (Türkiye)
- Antalya Şehir Hastanesi
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연락하다:
- MUSTAFA KILIN, CONSULTANT İN ANESTHESİOLOGY
- 전화번호: +905464569218
- 이메일: mustafa.kilin90@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic sleeve gastrectomy
- Body mass index (BMI) >35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) >35 kg/m²
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: Intertransverse Process Block (ITPB)
|
Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae. Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance. |
|
활성 비교기: Subcostal Transversus Abdominis Plane Block (TAPB)
|
After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned parallel to the lower costal margin. Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative pain intensity (VAS score)
기간: 0, 1, 4, 8, 12, and 24 hours after surgery
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Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity.
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0, 1, 4, 8, 12, and 24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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구제 진통 요법 필요성
기간: 수술 후 24시간 이내에
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수술 후 24시간 이내에
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수술 후 메스꺼움 및 구토의 유병률
기간: 수술 후 24시간 이내에
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수술 후 24시간 이내에
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환자 자가 조절 진통법(PCA)을 통한 전체 아편유사제 소비량
기간: 수술 후 첫 24시간 이내
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수술 후 첫 24시간 이내
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Quality of recovery assessed using the QoR-15 questionnaire
기간: At 24 hours postoperatively
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Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
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At 24 hours postoperatively
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Potential Complications
기간: Within the first 24 hours postoperatively
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Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
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Within the first 24 hours postoperatively
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Patient satisfaction
기간: At 24 hours postoperatively
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Patient and surgeon satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).
Higher scores indicate greater satisfaction.
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At 24 hours postoperatively
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공동 작업자 및 조사자
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 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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