Efficacy of TAP Block in Postoperative Pain Management for Elective Hysterectomy: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Consumption (Tramadol)
研究概览
简要总结
The goal of this study is to evaluate whether the Transversus Abdominis Plane (TAP) block can effectively reduce postoperative pain and opioid consumption in patients undergoing elective hysterectomy.
The main questions it aims to answer are:
Primary outcome: Does performing a pre-incisional TAP block reduce postoperative pain scores and opioid consumption compared to standard analgesic management?
Secondary outcomes:
Does TAP block reduce intraoperative opioid requirements during hysterectomy? Does TAP block enhance postoperative recovery and facilitate early mobilization? Does TAP block reduce the length of hospital stay? Does TAP block improve overall patient satisfaction following hysterectomy? If there is a comparison group: Researchers will compare patients receiving TAP block with lidocaine and ropivacaine (0.2%, 0.4 ml/kg per side) to patients receiving standard analgesia without TAP block to see if the TAP block provides superior pain relief, lowers opioid needs, and improves recovery outcomes.
Participants will:
Undergo elective total or subtotal hysterectomy. Receive either a TAP block (intervention group) or standard analgesic management (control group).
Have their intraoperative and postoperative opioid consumption, pain scores, recovery parameters, and satisfaction assessed.
详细描述
Hysterectomy is a common gynecological surgical procedure involving the removal of the uterus. The procedure may be total or subtotal, and is frequently associated with moderate to severe postoperative pain. Effective management of this pain is crucial and is typically achieved through multimodal analgesia. This approach includes regional nerve blocks, systemic analgesics (oral and intravenous), and adjunctive therapies (physical or psychological), resulting in reduced opioid requirements, minimized side effects, and shorter hospital stays.
The transversus abdominis plane (TAP) block is a regional anesthesia technique involving the injection of a local anesthetic between the transversus abdominis and internal oblique muscles. This targets the thoracolumbar nerves (T6-L1) and provides effective analgesia for the anterior abdominal wall. When performed under ultrasound guidance following abdominal surgery, the TAP block has demonstrated benefits including decreased incisional pain, reduced opioid consumption, and improved postoperative mobilization.
This is a prospective, randomized, comparative clinical trial conducted within the Department of Obstetrics and Gynecology at Mureș County Emergency Clinical Hospital. The study period extends from January 2024 to December 2025 or until the target sample size is reached. All anesthetic and surgical interventions utilized are within standard clinical practice; no experimental drugs or procedures are employed.
The study compares two multimodal analgesia protocols to identify the most effective and satisfactory method of postoperative pain management. All participants will provide written informed consent prior to enrollment.
Participants will be randomly allocated into two groups using a computer-generated randomization application on the day of surgery. The anesthesiologist performing the TAP block will be the only staff member aware of group allocation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective surgery
- •Subumbilical incision (median, Phannenstil)
- •Total or subtotal hysterectomy
- •Age over 18 years
排除标准
- •Patient refusal
- •Infection at the puncture site
- •Chronic pain
- •Chronic use of analgesics
- •Contraindications to NSAIDs, local anesthetics, or opioids (e.g., tramadol: antidepressants, epileptic disorders)
- •Severe hepatic disease
- •Renal insufficiency (Creatinine Clearance ≤ 30 ml/min)
- •Coagulopathy (Platelet count ≤ 75,000, INR ≥ 1.4)
研究组 & 干预措施
Arm 1: TAP Block with Lidocaine and Ropivacaine
Participants in this arm will receive a pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2% with a calculated dose of 0.4 ml/kg per side, in addition to standard analgesia.
干预措施: Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2% (Procedure)
Arm 2: Standard Analgesia (Control)
Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy. This regimen typically includes systemic analgesics (e.g., intravenous or oral non-opioid analgesics and opioids as needed) but does not include a Transversus Abdominis Plane (TAP) block.
干预措施: Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy (Drug)
结局指标
主要结局
Cumulative Opioid Consumption (Tramadol)
时间窗: From end of surgery (arrival in recovery room) to 24 hours postoperatively
Total intravenous Tramadol administered for postoperative pain management will be recorded during the first 24 hours following elective hysterectomy. Unit of Measure: Milligrams (mg) of IV Tramadol
Postoperative Pain Intensity
时间窗: From end of surgery to 24 hours postoperatively
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be recorded at 0, 1, 4, 6, and 24 hours postoperatively, both at rest and during movement.
次要结局
- Length of Hospital Stay(Up to 2 weeks)
- Intraoperative Opioid Consumption During Hysterectomy(From induction of anesthesia until completion of surgery)
- Postoperative Quality of Recovery Assessed by QoR-15(At 48 hours after completion of surgery)
- Patient Satisfaction with Postoperative Pain Management(At 24 hours after completion of surgery)
研究者
Matild Keresztes
Doctor
Tîrgu Mureș Emergency Clinical County Hospital, Romania