Efficacy of Unilateral Laparoscopic Transversus Abdominis Plane Block Compared to Local Infiltration in Postoperative Analgesia Following Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy
研究概览
简要总结
This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Pain scores, use of pain medication, and complications were measured up to 24 hours after surgery. The TAP block group experienced less pain and fewer wound-related problems, showing that this method is safe and effective for postoperative pain relief.
详细描述
Gallbladder stones are a common condition, and laparoscopic cholecystectomy is the standard treatment. Effective pain control after surgery is important for recovery and patient comfort. Traditionally, local anesthetic infiltration (LAI) at the surgical wound sites is used. Another method, the transversus abdominis plane (TAP) block, may provide better pain relief.
This prospective, randomized clinical trial was conducted at the University Clinical Hospital in Olsztyn, Poland. A total of 160 patients undergoing elective laparoscopic cholecystectomy were randomized into four groups: TAP block, LAI, TAP+LAI, and control. All patients received the same type of anesthesia and standard pain medications.
The primary goal was to compare pain intensity within 24 hours after surgery using the Numerical Rating Scale (NRS). Secondary measures included use of additional painkillers, recovery scores (Aldrete), and possible complications at the wound site. The influence of surgical drains and gallstone size on pain was also examined.
The study found that the unilateral laparoscopic TAP block provided the best pain relief, fewer wound-related complications, and reduced need for additional medications compared with other methods. These results suggest that the laparoscopic TAP block is a safe and effective option for improving postoperative pain management after gallbladder surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients were blinded to group allocation. The statistician analyzing the results was also blinded. Care providers performing the procedures were not blinded.
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 to 85 years
- •Scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis confirmed by ultrasonography
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Provided written informed consent
排除标准
- •ASA physical status III-IV
- •Contraindications to laparoscopy
- •Acute cholecystitis diagnosed preoperatively or perioperatively
- •Chronic analgesic use
- •Spinal degenerative joint disease
- •Known allergy to local anesthetics
- •Opioid or alcohol dependence
- •Psychiatric or neurological disorders
- •Lack of consent or withdrawal of consent
研究组 & 干预措施
TAP Block
Participants received a unilateral laparoscopic transversus abdominis plane (TAP) block performed under direct laparoscopic vision using 20 mL of 0.25% bupivacaine.
干预措施: Unilateral laparoscopic TAP block (0.25% bupivacaine) (Procedure)
Local Anesthetic Infiltration (LAI)
Participants received local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites under laparoscopic guidance.
干预措施: Local anesthetic infiltration (0.25% bupivacaine) (Procedure)
TAP + LAI
Participants received a combination of unilateral laparoscopic TAP block (10 mL of 0.25% bupivacaine) and local anesthetic infiltration at trocar sites (10 mL of 0.25% bupivacaine).
干预措施: Combined TAP block and local anesthetic infiltration (0.25% bupivacaine) (Procedure)
Control (No Regional Anesthesia)
Participants did not receive regional anesthesia. Postoperative pain management was provided only with standardized intravenous analgesics.
结局指标
主要结局
Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy
时间窗: Pain scores were recorded at 2 hours, 6 hours, and 24 hours after laparoscopic cholecystectomy during the first postoperative day.
Pain intensity was assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Scores were recorded by patients at rest at three time points after laparoscopic cholecystectomy: 2 hours, 6 hours, and 24 hours postoperatively. Pain was evaluated as an overall score and at specific surgical sites (umbilical, subcostal, and substernal wounds). Assessments were performed only when patients reached an adequate level of consciousness, verified by Aldrete score.
次要结局
- Use of rescue analgesics (metamizole, paracetamol, oxycodone) within 24 hours after laparoscopic cholecystectomy(Rescue analgesic use assessed at 6, 12, 18, and 24 hours after surgery during the first postoperative day.)
研究者
Łukasz Dyśko
Principal Investigator
University of Warmia and Mazury in Olsztyn