The Use of Pectoral Nerve Block Type II in Patients Undergoing Trans-axillary Thoracic Outlet Decompression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Pain Numeric Rated Scale
研究概览
简要总结
Rationale: Postoperative pain management after transaxillary thoracic outlet decompression surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a PECS II block is able to reduce pain and morphine consumption. This may ultimately lead to less morphine induced side-effects and improved patient satisfaction. However, the risk of bias in retrospective research is high. To determine the effect of PECS II in TATOD, a randomized controlled double blinded trial could offer more valuable scientific evidence. Our hypothesis is that a PECS II block will reduce pain, opioid use and opioid induced side-effects in patients undergoing transaxillary TOD (TATOD).
Objective: The aim of the study is to determine the effect of a PECS II block on postoperative pain and opioid use in patients undergoing TATOD. The secondary objective is to determine the effect of a PECS II block on opioid induced side effects such as postoperative nausea and vomitus and the quality of recovery Study design: Single centre randomized controlled double blinded trial Study population: All patients with Neurogenic Thoracic Outlet Syndrome (NTOS) selected for TATOD by the TOS multidisciplinary workgroup and based on the specifications in 2016 SVS reporting standards.
Intervention: The study group will receive a PECS II block with 40 ml ropivacaine 5 mg/ml. The control group will receive a PECS II block with 40 ml NaCL 0.9%.
Main study parameters/endpoints: Primary outcome parameters are postoperative pain using the Numeric Rated Scale (NRS) score assessed at rest and when moving and postoperative morphine-equivalent consumption. Secondary outcome parameters are postoperative Nausea and Vomitus (PONV) and Quality of Recovery questionnaire (QoR-15).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will undergo ultrasound guided injection, after induction of anaesthesia. The administration of the injection does not invoke any extra physical discom-fort. Possible complications include hematoma and pneumothorax, however, the risk is very low (<1%)[1]. In the intervention group, we expect less pain, a reduced need for pain medica-tion and less postoperative nausea and vomitus. We do not expect an altered postoperative course in the control group. Patients will be asked to fill out a questionnaire. Extra blood sam-ples, site visits, physical examinations or other test will not be done in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial. This pharmacist has no other task then creating this list and overseeing the preparation of the syringes used in this trial. Syringes will be prepared with ropivacaine or placebo based on this randomisation list. This syringe will be delivered to the preoperative holding with a label that clearly states BLOCKTOS medication, patient name, date of birth and patient number. This procedure makes sure that the patients, surgeons, anaesthesiologist and any other medical personnel are blinded for the randomisation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NTOS
- •Selected for a trans-axillary thoracic outlet decompression (TATOD) by the TOS multidisciplinary workgroup.
- •Fit for surgery, defined as ASA (American Society of Anesthesiologists) Classification of I, II or III.
- •18 years of age or older
- •Sufficient in speaking and writing the Dutch language
- •Normal liver and renal function
- •Informed consent
排除标准
- •Patients with a history of TOD (Redo-surgery)
- •Patients with ATOS or VTOS
- •Kidney or liver failure with contra-indication for NSAID or paracetamol
- •Mental retardation
- •Pregnancy
- •Patients with chronic strong opioid use (>3 administrations per week or continuous transdermal therapy, longer than the last 3 months)
- •Allergy to one or more medications used in the study including, ropivacaine, dexamethasone, propofol, sufentanil, succinylcholine, paracetamol, NSAID, morphine, granisetron
- •Patients that have trouble expressing themselves in Dutch. Questionnaires are completed by the patients and checked by the nurses. The questionnaire is in Dutch. If there is a language barrier between the questionnaire, the patient or the health care worker, we believe the validity of the answers is questionable.
研究组 & 干预措施
Interventional group
Intervention arm: PECS II block with ropivacaine
干预措施: Pectoral nerve block type II (Procedure)
Control group
Control arm: PECS II block with placebo (saline)
干预措施: Pectoral nerve block type II (Procedure)
结局指标
主要结局
Change in Pain Numeric Rated Scale
时间窗: Change pain NRS scale is measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain.
Morphine Equivalent Dose (MED)
时间窗: Total morphine equivalent dose is measured from date of admission until the date of discharge
Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption.
次要结局
- Quality of Recovery Scale - 15 (QoR-15)(measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge)
- Postoperative nausea and vomitus (PONV)(measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge)
研究者
Joep Teijink
Professor
Catharina Ziekenhuis Eindhoven