Efficacy of Adding Dexmedetomidine Versus Ibuprofen as an Adjuvant to Intraperitoneal Bupivacaine for Pain Control After Laparoscopic Gynecological Procedures: a Double-blind Randomized Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- effect on postoperative pain control
研究概览
简要总结
The goal of this clinical trial is to compare the analgesic efficacy of adding dexmedetomidine versus ibuprofen to bupivacaine for intraperitoneal instillation after laparoscopic gynecological procedures. The main questions to answer are:
- Which is more effective for controlling postoperative pain within the first 24 hours after the procedure?
- Which is more convenient for the patients with fewer side effects and opioid consumption?
Participants will be asked to assess
- The postoperative pain severity by VAS score
- The onset of the first analgesic request
- The incidence of side effects like nausea and vomiting Researchers will compare the dexmedetomidine group, the ibuprofen group, and the bupivacaine (control) group to see which one will be superior to the others.
详细描述
The patients will be randomly allocated by simple randomization using a computer program into two equal groups by closed envelope technique:
Group 1: Bupivacaine/Ibuprofen group (BI): Patients will receive 50ml bupivacaine 0.25% (125 mg) + 400 mg Ibuprofen diluted in 100 ml normal saline.
Group 2: Bupivacaine/Dexmedetomidine group (BD): Patients will receive 20 ml bupivacaine 0.25% (125 mg) + 1 µq/kg dexmedetomidine diluted in 100 ml normal saline.
Group 3: Control group/Bupivacaine group (B): Patients will receive 50 ml Bupivacaine 0.25% (125mg) diluted in 100 ml normal saline.
All the previous drugs will be injected intraperitoneally through trocars at the end of the 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, Care Provider)
盲法说明
The study drugs will be prepared in a ready-to-inject form by a separate anesthesiologist who is not involved in the study.
This way, neither the patient nor the anesthesiologist administering the drug will be aware of the type of medication being used.
The physician who will gather patient data is also unaware of the medications administered.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with American Society of Anesthesiologists (ASA) physical status 1-2 scheduled for a Laparoscopic gynecological procedure.
排除标准
- •History of allergy to the medications used in the study.
- •Contraindication as local infection at the site of port insertion.
- •Severe cardiac (NYHA ≥Ⅲ or pulmonary dysfunction (known COPD, previous thoracic surgeries, or recent pulmonary infection).
- •Severe hepatic impairment (Child C) (INR≥2, Albumin≤2.5).
- •Severe Renal dysfunction (creatinine clearance < 30).
- •Neurologic, a psychiatric or mental disorder affecting the patient's ability to interpret VAS score.
- •Body mass index (BMI) ≥ 40 or ≤ 18 kg/m
- •Patients who were converted to open surgery.
- •Patient refusal.
- •Emergency operations.
研究组 & 干预措施
Bupivacaine group (Group B) (control group)
Patients will receive 50 ml of Bupivacaine 0.25% (125mg) diluted in 100 ml of normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.
干预措施: Administering intraperitoneal bupivacaine for pain control after laparoscopic gynecological procedures (Drug)
Bupivacaine/Ibuprofen group (Group BI)
Patients will receive 50 ml of Bupivacaine 0.25% (125 mg) + 400 mg Ibuprofen diluted in 100 ml normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.
干预措施: Administering intraperitoneal bupivacaine plus Ibuprofen for pain control after laparoscopic gynecological procedures (Drug)
Bupivacaine/Dexmedetomidine group (Group BD):
Patients will receive 20 ml of bupivacaine 0.25% (125 mg) + 1 µq/kg dexmedetomidine diluted in 100 ml normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.
干预措施: Administering intraperitoneal bupivacaine plus Dexmedetomidine for pain control after laparoscopic gynecological procedures (Drug)
结局指标
主要结局
effect on postoperative pain control
时间窗: 24 hours after the procedure
Assessment of postoperative pain severity by Visual analog score (VAS score) (at 0 (the point of full recovery state at PACU), 6 hr., 12 hr., 18 hr., and 24 hr. after the end of the procedure) will be assessed.
次要结局
- Postoperative opioid consumption(24 hours after the procedure)
- Patient satisfaction(After 24 hours of the procedure)
- The onset of the first analgesic request(Within 24 hours after the procedure)
- Incidence of postoperative side effects(Within 24 hours after the procedure)
研究者
Wael El GHARABAWY
Assistant professor of anesthesiology, ICU, pain management
Ain Shams University