Effectiveness of Intrathecal Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in Patients Undergoing Transurethral Resection of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- VAS Pain score
研究概览
简要总结
The goal of this clinical trial is to compare pain after surgery in patients undergoing Transurethral Resection of Prostate. The main question it aims to answer are: Intrathecal nalbuphine as an adjuvant to local anesthetic will better provide pain relief after TURP surgery.
Participants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after surgery.
详细描述
This study aims to evaluate the efficacy and side effects of nalbuphine, with the goal of providing anesthesiologists with evidence-based guidance for selecting the most appropriate pharmacological agents for their patients.
Participants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for Transurethral Resection of Prostate under spinal anesthesia
- •American Society of Anesthesiologists (ASA) physical status I-III
排除标准
- •Allergy to study medications or hypersensitive to local anesthetics
- •Contraindicated for neuraxial anesthesia
- •Inability to self-report pain
- •Chronic opioid used
研究组 & 干预措施
Nalbuphine group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
干预措施: Nalbuphine Hydrochloride 10 MG/ML (Drug)
Nalbuphine group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
干预措施: Bupivacaine Hydrochloride, Spinal (Drug)
Nalbuphine group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
干预措施: Nalbuphine Hcl 10Mg/Ml Inj (Drug)
Nalbuphine group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
干预措施: Acetaminophen 500Mg Tab (Drug)
Nalbuphine group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal
干预措施: Ondansetron 8mg (Drug)
Control group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
干预措施: Sodium Chloride 0.9 % in 5 ML Injection (Drug)
Control group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
干预措施: Bupivacaine Hydrochloride, Spinal (Drug)
Control group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
干预措施: Nalbuphine Hcl 10Mg/Ml Inj (Drug)
Control group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
干预措施: Acetaminophen 500Mg Tab (Drug)
Control group
0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal
干预措施: Ondansetron 8mg (Drug)
结局指标
主要结局
VAS Pain score
时间窗: 12 hour postoperative
Pain score during motion 12 hours postoperatively was assessed using a standard 10 cm linear Visual Analogue Scale, where 0 represents the minimum score and 10 the maximum, with higher scores indicating worse outcomes.
次要结局
- Nausea and vomiting incidence(24 hour postoperative)
- VAS Pain score(24 hour postoperative)
- Time to first rescue analgesia(24 hour postoperative)
- Total analgesics consumption(24 hour postoperative)
- Pruritus incidence(24 hour postoperative)
- Sedation score(Ramsay sedation scale)(24 hour postoperative)