Improving Perioperative Pain Management for Laparoscopic Surgery Due to Colon Cancer Using the Ultrasound-guided Transmuscular Quadratus Lumborum Block. A Double Blind, Randomized, Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia.
An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.
Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen.
The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.
详细描述
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The vast majority of the patients has to have part of their colon removed, a so-called hemicolectomy. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia using a continuous intravenous (iv.) infusion of propofol and remifentanil to keep the patient asleep. As postoperative pain management the patients receive IV. paracetamol, IV. sufentanil (30 minutes prior to surgery) and local would infiltration.
At the post anaesthesia care unit (PACU) the patients are offered paracetamol and morphine as pain management. An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen as described, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.
Surgical technique:
The procedure is performed as a standard 4 port laparoscopic or robot-assisted technique with a vessel first dissection approach. The principles of complete mesocolic excision with is the standard procedure. The extraction site is for the right side and transverse colon through an upper transverse incision and for the left side and rectum through a pfannenstiel incision.
Anaesthesia and postoperative pain management:
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)
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
- •Age > 18
- •Scheduled for laparoscopic or robot assisted hemicolectomy or sigmoidectomy due to colon cancer
- •Have received thorough information, oral and written, and signed the "Informed Consent" form on participation in the trial
- •American Society of Anaesthesiologist physical status classification, class 1-3
排除标准
- •Inability to cooperate
- •Inability to speak and understand Danish
- •Allergy to local anaesthetics or opioids
- •Daily intake of opioids (evaluated by the investigators)
- •Drug and/or substance abuse
- •Local infection at the site of injection or systemic infection
- •Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
- •Pregnant* or breastfeeding
- •Daily use of oral or intravenous steroids
- •Known immune deficiency (evaluated by the investigators)
- •Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer) within the last five years (within the last five years added 28th nov 2019 after ethics committee approval).
研究组 & 干预措施
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Ropivacaine (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Acetaminophen (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Patient controlled analgesia (Device)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Morphine (Drug)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Blood samples (Diagnostic Test)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Quality of recovery-15 questionaire (Behavioral)
Active
Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Orthostatic hypotension (Diagnostic Test)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Acetaminophen (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Patient controlled analgesia (Device)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Morphine (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Saline (Drug)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Blood samples (Diagnostic Test)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Quality of recovery-15 questionaire (Behavioral)
Placebo
Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
干预措施: Orthostatic hypotension (Diagnostic Test)
结局指标
主要结局
Total morphine consumption
时间窗: Twenty-four hours postoperative
Data from PCA pump and patient medical record
次要结局
- Time to discharge(30 days after surgery)
- Pain at rest(Registered upon arrival at the PACU and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.)
- Pain upon ambulation (walking 5 meters with aid)(At 3, 6 and 24 hours postoperative)
- Pain during mobilisation(Registered upon arrival at the postanaesthesia care unit (PACU) and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.)
- Heart Rate Variability (HRV)(From block administration and to 24 hours postoperative)
- tumor necrosis factor alpha(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-17a(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-8(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-10(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-11(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-15(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-17f(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-18(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-22(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Hemoglobin(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Leucocytes including differential count(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Thrombocytes(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- The degree of morphine-related side effects. Nausea or post anaesthesia nausea and vomiting (PONV) registered in the case report form, if any.(24 hours postoperative)
- Orthostatic hypotension (yes/no) and orthostatic intolerance i.e. symptoms of orthostatic hypotension without a drop in blood pressure (yes/no).(Before surgery and at 3, 6 and 24 hours postoperative)
- Quality of Recovery - 15 questionnaire(Preoperatively and day 1+2 and 10-14 post surgery)
- Alanine aminotransferase (ALAT)(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Bilirubin(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Prothrombin time (International normalized ratio)(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- An integrated assessment of longitudinally measured pain intensity and opioid consumption(0-24 hours postoperative)
- Morphine consumption(At 6, 12, 18 postoperative hours.)
- Duration of block(Time to first opioid within the first 24 postoperative hours)
- Surgical complications(30 days post surgery)
- Whole blood gene expression profiling(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin -2(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-1b(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- interleukin-6(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- C reactive Protein(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Glucose(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Granulocyte-macrophage colony-stimulating factor(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Lactate dehydrogenase(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Albumin(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Sodium(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)
- Potassium(Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery)