Comparison of The Effects of Subcostal Anterior Quadratus Lumborum Block and Intrathecal Morphine on Postoperative Acute Pain in Laparoscopic Nephrectomy Surgery: A Randomized, Single-Blind, Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cumulative equivalent morphine consumption in the first 24 hours after surgery
研究概览
简要总结
In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and İntrathecal morphine (ITM) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.
详细描述
For all patients undergoing surgery, analgesic medications and techniques are routinely administered preoperatively, intraoperatively, and postoperatively to relieve their pain. Depending on the method applied, patients' analgesic needs in the recovery room and ward after surgery may vary. In patients undergoing laparoscopic nephrectomy, multimodal analgesia (paracetamol, nonsteroidal anti-inflammatory drugs, and opioids) is routinely applied in our clinic, utilizing various regional techniques or intravenous analgesics .
Opioids are the gold standard for postoperative pain control; however, they increase the incidence of opioid-related adverse effects such as dizziness, nausea, vomiting, constipation, and respiratory depression. Therefore, minimizing opioid use and its side effects is essential for postoperative pain control. Regional analgesia is a beneficial method for reducing opioid consumption and postoperative pain. It may also reduce postoperative morbidity and mortality.
Recently, interfascial plane blocks have been used for postoperative pain control in abdominal surgeries. The quadratus lumborum block (QLB) is a relatively new interfascial plane block technique in which local anesthetics are injected adjacent to the quadratus lumborum muscle. There are four different approaches to the QLB: anterior, intramuscular, lateral, and posterior. Anterior QLB involves the injection of a local anesthetic between the quadratus lumborum (QL) muscle and the psoas muscle. The dermatome coverage is determined by the injection site. The injection of local anesthetic anterior to the QL muscle potentially allows the drug to spread into the thoracic paravertebral space, blocking the somatic and sympathetic nerves of the lower thoracic segments. This situation helps us achieve more effective analgesia in abdominal surgeries.
Intrathecal morphine (ITM) is an emerging strategy for postoperative analgesia following major abdominal surgery. Traditional spinal analgesia protocols often rely on continuous thoracic epidural anesthesia due to their ability to provide adequate analgesia with a few cardiopulmonary complications. However, epidural anesthesia is also associated with more frequent perioperative hypotension, technical failures, increased fluid administration, and longer length of stay (LOS). Therefore, ITM is an attractive alternative because it offers easier administration, potent efficacy at low doses, and reduced postoperative complications, providing a form of spinal analgesia that can be used when epidural catheters are contraindicated.
The analgesic properties of ITM have been demonstrated in recent studies involving cardiac, gynecological, spinal, orthopedic, urological, colorectal, hepatopancreatobiliary, and major abdominal surgeries. With an estimated duration of action of up to 24 hours, these studies have focused on the initial postoperative recovery period and generally found lower pain scores and, in some cases, reduced early postoperative opioid requirements. Intrathecal morphine has been successfully used for postoperative pain in various surgeries. Being a hydrophilic opioid, morphine's limited sequestration in adipose tissue delays its clearance from the cerebrospinal fluid compared to other opioids. As a result, the analgesic effects of intrathecal morphine last longer, providing up to 24 hours of analgesia without the need for indwelling catheters or continuous infusions. Direct injection into the intrathecal space also allows morphine to act directly on opioid receptors in the brain and the substantia gelatinosa of the spinal cord, providing a potent analgesic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based;Research Randomizer; (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio.
A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the block/blocks about which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years who had an American Society of Anesthesiologists (ASA) Physical Status classification I-III
排除标准
- •refusal to participate in the study
- •body mass index>35 kg/m2
- •contraindications to peripheral nerve blocks or spinal anesthesia (e.g., the presence of coagulopathy or pre-existing local or systemic infection etc.)
- •unable to perform regional anesthesia because of anatomical deformity
- •clinically important cardiovascular and cerebrovascular diseases or preexisting significant organ dysfunction (eg, hepatic, renal or respiratory disorders)
- •allergic reaction to any study drugs
- •history of substance
- •abuse within the three-month period prior to surgery, chronic opioid use for at least a continuous administration of opioids for a duration of 30 days at daily morphine-equivalent dose ≥15 mg/d (1)
- •psychiatric illness and disorder in communication.
研究组 & 干预措施
Group S-QLB3
S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA
干预措施: Subcostal Anterior Quadratus Lumborum Block (Procedure)
Group S-QLB3
S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA
干预措施: Patient Controlled Analgesia (IV PCA) (Drug)
Group ITM
ITM Morphine (a total of 0.2 mg of morphine sulfate + 7.5 mg isobaric (plain) bupivacaine ) + iv morphine-PCA
干预措施: Intrathecal Morphine (Procedure)
Group ITM
ITM Morphine (a total of 0.2 mg of morphine sulfate + 7.5 mg isobaric (plain) bupivacaine ) + iv morphine-PCA
干预措施: Patient Controlled Analgesia (IV PCA) (Drug)
结局指标
主要结局
Cumulative equivalent morphine consumption in the first 24 hours after surgery
时间窗: postoperative day 1
Cumulative equivalent morphine consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4. In cases where rescue analgesia is required (NRS score ≥4), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.
次要结局
- Postoperative pain scores(postoperative day 1)
- Patients satisfaction and quality of pain management(preoperatively, postoperative day 1 and the 1 day of discharge)
- intraoperative total remifentanil consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.)
- The heart rate measurement(The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes)
- The mean arterial pressure measurement(The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.)
- The number of patients requiring rescue analgesics(postoperative day 1)
- Cumulative equivalent morphine consumption in the first 12 hours after surgery(postoperative day 1)
- The number of patients requiring postoperative antiemetics.(postoperative day 1)
- Sedation score(postoperative day 1)
- Time of first analgesic request(postoperative day 1)
- The morbidity of patients(Postoperative 1 month on an average)
- Complications(Postoperative 1 month on an average)
- The incidences of post-operative pruritus(Postoperative day 1)
研究者
Cengiz KAYA
Professor Dr
Ondokuz Mayıs University
