Intercostal Nerve Block for Pain Management After Uniportal Video-assisted Thoracoscopic Surgeries

Официальное название

Internal, External Intercostal Nerve Block and Intercostal Catheter for Pain Management After Uniportal VATS: A Clinical Trial

Обзор

The goal of this clinical trial is to compare the safety and effectiveness of the three intercostal nerve blocks used in pain management in uniportal (one port) thoracoscopic surgeries: internal intercostal nerve blocks (ICNB), external ICNB, and Intercostal catheters. Participants will be randomly assigned to three groups: * First group will undergo internal intercostal nerve block * Second group will be given external intercostal nerve block * Third group will have an intercostal catheter Researchers will compare the three groups to see their impact on post-operative pain management in uniportal VATS.

Подробное описание

The main questions this clinical trial aims to answer are:

1. To study post-VATS complications, such as: postoperative air leak, post-operative pain, hypoxemia, atelectasis, bleeding, wound infection, pneumonia, Deep Vein Thrombosis, pulmonary embolism and their association with the different approaches of ICNBs. 2. To address the cost-effectiveness of the intercostal nerve block approaches. 3. To study the participants' level of satisfaction after VATS following each procedure of ICNB. 4. To address the relationships between the intercostal nerve block approaches and participants' characteristics such as age, gender, BMI, medical and surgical history, smoking, and alcohol history.

This study is a randomized controlled trial that will take place at Al-Ahli Hospital and Saint Joseph Hospital. The trial will involve 90 participants, who will be randomly assigned to three groups. Of these, group 1 will include 30 participants who'll receive an internal intercostal nerve block, group 2: 30 participants will receive an external intercostal block, and group 3 are the 30 participants who will have an intercostal catheter inserted.

Data will be collected from the participants' themselves through a questionnaire before the surgery. The participants will be followed up after the surgery (3, 6, 24 hours post-operatively) in order to obtain the numerical rating scale. A written informed consent will be sought.

Data Analysis will be done through International Business Machines (IBM) Statistical Package for Social Sciences (SPSS) for Windows Version 16.

Вмешательства

• Другое External Intercostal Nerve Block
  External ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space from outside the chest wall.
• Другое Internal Intercostal Nerve Block
  Internal ICNB: A mixture of analgesics will be given through a needle inserted in the intercostal space inside the chest wall under direct thoracoscopic vision.
• Другое Intercostal Catheter
  Intercostal Catheter: it will be put 1-2 intercostal spaces above the VATS incision, and the participant will receive the 15 cc of the previously mentioned mixture every 8 hours for two to three days.

Первичные конечные точки

• The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS [Срок оценки: From participants enrollment until 3 hours after the surgery]
• The effectiveness of the three approaches of pain management after 6 hours of uniportal VATS [Срок оценки: From participants enrollment until 6 hours after the surgery]
• The effectiveness of the three approaches of pain management after 24 hours of uniportal VATS [Срок оценки: From participants enrollment until 24 hours after the surgery]
• The effectiveness of the three approaches of pain management after uniportal VATS [Срок оценки: From participants enrollment and during the 24 hours post-operatively]
• The effectiveness of the three approaches of pain management after uniportal VATS, during different positions [Срок оценки: 24 hours post-operatively]

Вторичные конечные точки (7)

• The effect of the three different approaches of pain management on post-operative hypoxemia [Срок оценки: From participants enrollment until 3 hours after the uniportal VATS]
• The effect of the three different approaches of pain management on post-operative hypoxemia [Срок оценки: From participants enrollment until 6 hours after the uniportal VATS]
• The effect of the three different approaches of pain management on post-operative hypoxemia [Срок оценки: From participants enrollment until 24 hours after the uniportal VATS]
• The effect of the three different approaches of pain management on post-operative atelectasis [Срок оценки: From participants enrollment until 24 hours after the uniportal VATS]
• The effect of the three different approaches of pain management on post-operative Pneumothorax [Срок оценки: From participants enrollment until 24 hours after the uniportal VATS]
• Cost-effectiveness of the three approaches [Срок оценки: From participants enrollment until the study completion, an average of 7 months]
• Participants' satisfaction level [Срок оценки: From participants enrollment until 24 hours after the uniportal VATS]

Критерии участия

Критерии включения

• All participants between the ages of 18 and 80 year-old who have elective or urgent uniportal VATS will be included in the sample.

Критерии исключения

• Children - under the age of 18 or participants above the age of 80.
• Participants with chest wall infections and those with decorticated lungs will be excluded from the study.
• Participants with pre-existing chest pain or severe renal or hepatic dysfunction
• Participants with a history of psychiatric disorder or inability to understand the consent form or how to use a Numerical Rating Scale (NRS) for pain measurement
• Participants who have allergy to any of the given drugs, second thoracic surgery, participation in other clinical trials, obesity with body mass index>35 kg/m2, intake of antiplatelet or anticoagulant agents, spinal deformity and severe bradycardia will also be excluded.
• Participants will be withdrawn from the study if the technical failure happened in the block or VATS procedure was converted to open procedure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Palestinian Territories · 2 центра

• Saint Joseph Hospital — East Jerusalem
• Al-Ahli Hospital — Hebron

Публикации

• Mehrotra M, D'Cruz JR, Bishop MA, Arthur ME. Video-Assisted Thoracoscopy. 2024 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532952/ PMID 30422547
• Kirby TJ, Mack MJ, Landreneau RJ, Rice TW. Initial experience with video-assisted thoracoscopic lobectomy. Ann Thorac Surg. 1993 Dec;56(6):1248-52; discussion 1252-3. doi: 10.1016/0003-4975(93)90661-z. PMID 8267420
• Rocco G, Martin-Ucar A, Passera E. Uniportal VATS wedge pulmonary resections. Ann Thorac Surg. 2004 Feb;77(2):726-8. doi: 10.1016/S0003-4975(03)01219-0. PMID 14759479
• Kim S, Bae CM, Do YW, Moon S, Baek SI, Lee DH. Serratus Anterior Plane Block and Intercostal Nerve Block after Thoracoscopic Surgery. Thorac Cardiovasc Surg. 2021 Sep;69(6):564-569. doi: 10.1055/s-0040-1705152. Epub 2020 Mar 29. PMID 32222960
• Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5. PMID 34739134
• Detterbeck FC. Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. Ann Thorac Surg. 2005 Oct;80(4):1550-9. doi: 10.1016/j.athoracsur.2004.11.051. PMID 16181921
• Guerra-Londono CE, Privorotskiy A, Cozowicz C, Hicklen RS, Memtsoudis SG, Mariano ER, Cata JP. Assessment of Intercostal Nerve Block Analgesia for Thoracic Surgery: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Nov 1;4(11):e2133394. doi: 10.1001/jamanetworkopen.2021.33394. PMID 34779845
• Okmen K, Okmen BM, Uysal S. Serratus Anterior Plane (SAP) Block Used for Thoracotomy Analgesia: A Case Report. Korean J Pain. 2016 Jul;29(3):189-92. doi: 10.3344/kjp.2016.29.3.189. Epub 2016 Jul 1. PMID 27413485

Идентификаторы

NCT: NCT06838026 · 20222023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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