Effect of Dexamethasone and Bupivacaine on Postoperative Pain Following Total Extraperitoneal Hernioplasty: A Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Postoperative Pain Scores
研究概览
简要总结
This study looked at whether a combination of two medicines, dexamethasone and bupivacaine, can reduce pain after laparoscopic hernia surgery. A total of 175 patients who had elective total extraperitoneal (TEP) hernia repair were randomly assigned to two groups. One group received a spray of dexamethasone and bupivacaine around the surgical mesh, while the other group did not receive any local treatment.
Pain levels were measured at 3, 6, and 12 hours after surgery using a visual pain scale. The need for additional pain medicine and patient satisfaction were also recorded. Patients who received dexamethasone and bupivacaine reported lower pain scores, needed less extra pain medicine, and were more satisfied with their pain control compared to the control group.
The results suggest that this simple, safe, and low-cost method may help improve pain control and comfort after laparoscopic hernia repair.
详细描述
This randomized controlled study investigated the effect of adding dexamethasone to bupivacaine for pain management after laparoscopic total extraperitoneal (TEP) hernia repair. Postoperative pain is still a significant concern after TEP, even though this minimally invasive technique generally causes less pain than open surgery. Local anesthetics such as bupivacaine are widely used, but their effect is limited in duration. Dexamethasone, an anti-inflammatory corticosteroid, has been shown to enhance and prolong analgesia when combined with local anesthetics.
A total of 175 patients undergoing elective unilateral TEP hernioplasty were randomized into two groups. The intervention group received 20 mg of bupivacaine (4 mL of 0.5%) mixed with 8 mg dexamethasone, sprayed directly on the surgical mesh and surrounding tissues after mesh placement. The control group did not receive any local treatment in the operative field. All patients received standard postoperative analgesia.
Pain scores were assessed using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery. The need for additional analgesics, patient satisfaction, and early complications were also recorded.
Results showed that patients in the dexamethasone + bupivacaine group had significantly lower pain scores at all time points, required fewer additional analgesics, and reported higher satisfaction compared to controls. No increase in surgical complications was observed.
This study suggests that the local application of dexamethasone combined with bupivacaine is a safe, simple, and cost-effective method to improve early postoperative pain control and patient comfort after laparoscopic TEP hernia repair.
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
- Single (Outcomes Assessor)
盲法说明
Pain scores were assessed by an independent health care provider who was blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) scheduled for elective unilateral inguinal hernia repair with the laparoscopic total extraperitoneal (TEP) technique
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Ability to provide informed consent
排除标准
- •Age <18 years
- •ASA physical status ≥III
- •Recurrent or bilateral inguinal hernia
- •History of allergy to local anesthetics or corticosteroids
- •Chronic opioid use or dependence
- •Severe hepatic, renal, or cardiac disease
- •Pregnancy or breastfeeding
- •Patients who declined to participate or could not provide consent
研究组 & 干预措施
Experimental: Intervention Group
Patients received 20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone. The solution was sprayed over the mesh and surrounding tissues after mesh placement during laparoscopic total extraperitoneal (TEP) hernioplasty.
干预措施: Bupivacaine + Dexamethasone (Drug)
结局指标
主要结局
Postoperative Pain Scores
时间窗: 12 hours after surgery
Pain intensity measured using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery.
次要结局
- Additional Analgesic Requirement(24 hours after surgery)
- Patient Satisfaction(Within 24 hours after surgery)
- Postoperative Complications(Within 30 days after surgery)
研究者
Gürkan Değirmencioğlu
General Surgery Specialist
Ankara Etlik City Hospital