Bilateral Ultrasound-guided External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cumulative opioid consumption in the first 24 hours after surgery
研究概览
简要总结
In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. This study aimed to evaluate the impact of the external oblique intercostal block postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic sleeve gastrectomy surgery.
详细描述
Adequate pain control in laparoscopic surgeries is associated with reduced postoperative opioid administration, faster mobilization, faster recovery, and shorter hospital stays. Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Laparoscopic bariatric procedures are most often associated with moderate to severe visceral pain from surgical manipulation of the stomach and intestine. Combined regional and general anesthesia reduces surgical stress responses by interrupting pain transmission signals, which facilitates pain control, reduces opioid consumption, and improves patient postoperative satisfaction. Ultrasound-guided fascial plane blocks have been rapidly included in regional anesthesia applications as an alternative to neuraxial techniques in recent years and include injection into a tissue plane to provide analgesia in various anatomical areas. The external oblique intercostal block (EOIB) represents an essential modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall. The EOIB block has easily identifiable sonographic points.
The study aims to investigate the effects of the EOIB on postoperative pain in morbidly obese patients who will undergo laparoscopic sleeve gastrectomy by comparing it with the control group. It is seen that there are not enough studies on EOIB in the literature. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, single-blind, parallel-group study.
Patients will be divided into two groups:
Group EOIB :
A bilateral EOIB (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
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 administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between18-65 years
- •American Society of Anesthesiology score II-III
- •Body mass index (BMI) > 35 kg/m2
- •Patients who will sign the informed consent form
排除标准
- •Patients with drug allergies (Opioids, NSAIDs, local anesthetics)
- •Patients with neuro-psychiatric disease, cognitive impairment, inability to communicate, or a history of drug addiction
- •Presence of any systemic infection or at the injection site
- •Patients taking anticoagulants or having any bleeding disorder (Coagulopathy, International Normalized Ratio (INR) value not within normal limits, thrombocytopenia or platelet dysfunction)
- •Patients with significant cardiovascular, hepatic, renal or endocrine disorders
- •Patients with a history of chronic pain syndromes or receiving chronic pain treatment and a history of opioid use for more than four weeks in the preoperative period
- •Patients using continuous positive airway pressure device due to obstructive sleep apnea syndrome (OSAS) (symptoms detected by polysomnography and apnea-hypopnea index (AHI) >5/hour)
- •Patients with chronic obstructive pulmonary disease
- •Patients who need intensive care unit after surgery
- •Patients who do not consent/do not want to participate
结局指标
主要结局
Cumulative opioid consumption in the first 24 hours after surgery
时间窗: postoperative day 1
Cumulative opioid 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
- Intraoperative 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 number of patients with complications(Postoperative 7 days on an average)
- 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 scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.(postoperative day 1)
- Patients' satisfaction and quality of pain management(postoperative day 1)
- 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.)
- Cumulative opioid consumption in the first 12 hours after surgery(postoperative day 1)
- Postoperative pain scores(postoperative day 1)
- The number of patients who required rescue analgesia.(postoperative day 1)
- Time of first analgesic request(postoperative day 1)
研究者
Cengiz KAYA
Principal Investigator, Clinical Professor
Ondokuz Mayıs University