Bilateral Ultrasound-guided M-Tapa Block vs 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
- 66
- 试验地点
- 1
- 主要终点
- Morphine 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 investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy.
详细描述
Morbid obesity patients often have multisystem physiological changes and multiple comorbidities that can significantly affect perioperative pain control. These patients may have increased side effects from inadequate acute pain management and opioids should be used with caution.
Regional techniques can be applied in obese patients because they provide non-opioid analgesia and have fewer perioperative respiratory side effects. Effective pain control is associated with reduced post-operative opioid administration, faster mobilization, faster recovery, and shorter hospital stay.
Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Recently, it has been reported that the M-TAPA block is a promising new technique that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is delivered only to the underside of the perichondral surface.
TAPA/M-TAPA block has been shown to provide a potent analgesic effect in a large abdomen by numbing both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. Therefore, the TAPA/M-TAPA block has been used in various abdominal surgeries. The EOI block represents an important modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall.
When we look at the literature, it is seen that there are not enough studies on M-TAPA block and EOIB.
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
Researchers, surgeons and nurses, and those involved in study outcome analysis will not be aware of the randomization of the group. Block quality and standardization will be performed by an anesthetist experienced in regional anesthesia for EOIB and M-TAPA block.
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
- •History of opioid use for more than four weeks
- •Chronic pain syndromes
- •Patients with a history of local anesthetic or opioid allergy, hypersensitivity
- •Severe cardiac, hepatic, and renal disease
- •Alcohol and drug addiction
- •Conditions where regional anesthesia is contraindicated
- •Failure in the dermatomal examination performed after the block
- •Patients with a STOP-BANG score ≥5
研究组 & 干预措施
Group M-TAPA
A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
干预措施: Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (Procedure)
Group M-TAPA
A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
干预措施: IV morphine patient-controlled analgesia (PCA) (Drug)
Group EOIB
A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
干预措施: Bilateral ultrasound guided external oblique intercostal block (EOIB) (Procedure)
Group EOIB
A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
干预措施: IV morphine patient-controlled analgesia (PCA) (Drug)
结局指标
主要结局
Morphine consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
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.
次要结局
- The number of patients with complications(Postoperative 7 days on an average)
- Postoperative pain scores(Postoperative day 1)
- Patients' satisfaction and quality of pain management(Postoperative day 1)
- The incidences of postoperative nausea and vomiting (PONV)(Postoperative day 1)
- Time of first analgesic request(Postoperative day 1)
- 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 who required rescue analgesia.(Postoperative day 1)
研究者
BURHAN DOST
Associate Professor
Ondokuz Mayıs University