Dexmedetomidine Versus Ketamine as an Adjuvant to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Total Abdominal Hysterectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total postoperative morphine consumption in miligram (mg)
研究概览
简要总结
Total abdominal hysterectomy is associated with significant postoperative pain due to abdominal wall incision and tissue manipulation. Effective pain management after surgery helps improve patient comfort, early mobilization, and recovery while reducing the need for opioid medications and their related side effects.
The transversus abdominis plane (TAP) block is a regional anaesthesia technique that provides pain relief by blocking sensory nerves supplying the abdominal wall. However, the duration of analgesia provided by local anaesthetic alone may be limited. Adding adjuvant drugs such as dexmedetomidine or ketamine may enhance and prolong the analgesic effect.
This randomized controlled trial aims to compare the effectiveness of dexmedetomidine and ketamine as adjuvants to bupivacaine in ultrasound-guided bilateral TAP block for postoperative pain management following total abdominal hysterectomy.
Participants undergoing elective total abdominal hysterectomy will be randomly assigned to receive either bupivacaine with dexmedetomidine or bupivacaine with ketamine during TAP block. Postoperative pain intensity, morphine consumption, time to first rescue analgesia, haemodynamic changes, sedation level and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery.
The findings of this study may help determine which adjuvant provides better postoperative analgesia when combined with bupivacaine for TAP block in patients undergoing total abdominal hysterectomy.
详细描述
Postoperative pain following total abdominal hysterectomy is influenced by both somatic and visceral components. The abdominal wall incision contributes significantly to somatic pain, while pelvic tissue manipulation contributes to visceral pain. Effective perioperative analgesia is essential to facilitate recovery and reduce opioid-related adverse effects.
The transversus abdominis plane (TAP) block is an established regional anaesthesia technique that provides analgesia by depositing local anaesthetic within the fascial plane between the internal oblique and transversus abdominis muscles, thereby reducing transmission of nociceptive signals from the abdominal wall. However, the duration of analgesia achieved with local anaesthetic alone may be limited, leading to interest in the use of adjuvant medications to enhance and prolong analgesic effects.
Dexmedetomidine and ketamine have different pharmacological mechanisms that may contribute to improved analgesia when combined with local anaesthetics. Dexmedetomidine, an α2-adrenergic receptor agonist, may enhance peripheral nerve block effects through modulation of neuronal excitability and nociceptive transmission. Ketamine, through NMDA receptor antagonism, may reduce central sensitization and hyperalgesia. Although both agents have demonstrated analgesic benefits in regional anaesthesia, comparative evidence regarding their relative effectiveness as adjuvants in TAP block for patients undergoing total abdominal hysterectomy remains limited.
This study is designed to generate comparative evidence regarding the analgesic efficacy and safety profile of these two commonly used adjuvant agents when administered with bupivacaine in ultrasound-guided TAP block. The findings may contribute to optimizing multimodal analgesic strategies and improving postoperative recovery after major gynaecological 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)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective total abdominal hysterectomy
- •ASA physical status I-II
- •Age 25-60 years
排除标准
- •Allergy to local anaesthetics
- •Patient refusal
- •Local infection/inflammation at block site
- •Anatomical deformity
- •Coagulopathy or bleeding disorder
- •Chronic pain syndrome
- •Chronic opioid consumption (>2 weeks)
- •Severe cardiac, hepatic, renal, or psychiatric disorders
研究组 & 干预措施
Bupivacaine with Dexmedetomidine TAP Block
Participants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block using 0.25% bupivacaine combined with dexmedetomidine as an adjuvant. A total volume of 30 mL of bupivacaine solution (15 mL per side) will be administered, with a total dose of 0.5 µg/kg dexmedetomidine, divided equally between both sides. The TAP block will be performed after induction of general anaesthesia and tracheal intubation, before the start of surgery.
干预措施: Dexmedetomidine & Bupivacaine (Drug)
Bupivacaine with Ketamine TAP Block
Participants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block with 0.25% bupivacaine and ketamine hydrochloride as an adjuvant. A total volume of 30 mL of bupivacaine solution (15 mL per side) will be administered, with a total ketamine hydrochloride dose of 1 mg/kg, divided equally between both sides. The TAP block will be performed after induction of general anaesthesia and tracheal intubation, before the start of surgery.
干预措施: Ketamine Hydrochloride and Bupivacaine (Drug)
结局指标
主要结局
Total postoperative morphine consumption in miligram (mg)
时间窗: 24 hours after surgery
Total morphine sulfate consumption during the first 24 postoperative hours.
次要结局
- Postoperative Pain Intensity(2, 4, 6, 12, and 24 hours after surgery)
- Time to First Rescue Analgesic Request(First 24 hours after surgery)
- Heart Rate (HR)(Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery)
- Systolic Blood Pressure (SBP)(Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery)
- Diastolic Blood Pressure (DBP)(Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery)
- Mean Arterial Pressure (MAP)(Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery)
- Postoperative Nausea and Vomiting (PONV)(Within 24 hours after surgery)
- Sedation Level (Ramsay Sedation Score)(2, 4, 6, 12, and 24 hours after surgery)
研究者
Kazi Mahzabin Arin
Assistant Professor
Bangladesh Medical University