Comparison of the Effects of M-TAPA Versus the Combination of M-TAPA and EXOP Blocks on Postoperative Pain in Laparoscopic Gynecologic Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (NRS)
研究概览
简要总结
Laparoscopic gynecologic surgery is less invasive than open surgery, but many patients still experience pain after the procedure. M-TAPA and EXOP are ultrasound-guided regional anesthesia techniques used to reduce abdominal pain. Previous research suggests that M-TAPA provides effective pain relief on the anterior abdominal wall, while EXOP may help reduce pain in the lateral abdominal region. This study aims to determine whether combining M-TAPA with EXOP provides better postoperative pain control than using M-TAPA alone. The study will compare pain scores during the first 24 hours after surgery, the need for rescue analgesic medication, and recovery quality using the QoR-15 questionnaire. All procedures are part of routine clinical care, and no experimental drugs or devices are used.
详细描述
In routine practice at our institution, anesthesia clinicians performing gynecologic laparoscopic procedures administer either modified thoracoabdominal nerve block through perichondrial approach (M-TAPA Block) alone or a combination of M-TAPA and external oblique muscle plane (EXOP) blocks, based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either M-TAPA or M-TAPA + EXOP will be included and evaluated observationally. Block types other than these two will not be included.
All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, administering the QoR-15 questionnaire, and evaluating sensory block distribution using the pinprick test.
Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. The researcher obtains informed consent, records demographic data, and administers the preoperative QoR-15 questionnaire.
In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied, intravenous access is established, and crystalloid infusion is initiated. Anesthesia induction is performed using propofol, an opioid, and a neuromuscular blocking agent, followed by endotracheal intubation. General anesthesia is maintained with sevoflurane in an oxygen-air mixture. Laparoscopic surgery is performed with gradual CO₂ insufflation, maintaining intra-abdominal pressure below 12 mmHg.
For postoperative analgesia, all patients routinely receive 1 g intravenous paracetamol and 100 mg tramadol. After surgery, neuromuscular blockade is reversed and patients are transferred to the post-anesthesia care unit (PACU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic gynecologic surgery
- •Age 18-90 years
- •ASA physical status I-III
排除标准
- •Contraindications to block procedures (coagulopathy, anticoagulant therapy, local infection at needle insertion site, etc.)
- •Severe cardiac, renal, hepatic, hematologic, neurologic, or psychiatric disease
- •Allergy to amide-type local anesthetics
- •Chronic pain, narcotic or alcohol dependence
- •BMI ≥ 35 kg/m²
- •Pregnancy
- •Refusal to participate
- •Conversion from laparoscopy to laparotomy
研究组 & 干预措施
Group M
Participants who received a bilateral M-TAPA block performed pre-extubation as part of routine anesthesia practice.
干预措施: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (Procedure)
Group E
Participants who received a combined bilateral M-TAPA block and external oblique plane (EXOP) block performed pre-extubation as part of routine anesthesia practice.
干预措施: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach And External Oblique Muscle Plane Block (Procedure)
结局指标
主要结局
Postoperative Pain Score (NRS)
时间窗: 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and will be compared between Group M and Group E. The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
Postoperative Pain Score (NRS)
时间窗: 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at 1, 2, 6, 12, and 24 hours after surgery and will be compared between Group M and Group E. The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
次要结局
- Quality of Recovery (QoR-15 Score)(Preoperative baseline and postoperative 24th hour)
- Rescue Analgesic Requirement(First 24 hours after surgery)
- Rescue Analgesic Requirement(First 24 hours after surgery)
- Quality of Recovery (QoR-15 Score)(Preoperative baseline and postoperative 24th hour)
研究者
Güneş Özlem Yıldız
Associate Professor, Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital