Comparison of Pain Relief by Bupivacaine With Dexmedetomidine and Bupivacaine Alone in Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Pain Relief (Visual Analogue Scale - VAS)
研究概览
简要总结
This study investigates the effectiveness of adding dexmedetomidine to bupivacaine for postoperative analgesia in patients undergoing abdominal surgeries. The research compares pain relief in two groups: one receiving a combination of bupivacaine and dexmedetomidine via a transversus abdominis plane (TAP) block, and the other receiving bupivacaine alone. The study aims to evaluate whether dexmedetomidine enhances pain relief, reduces the need for additional pain medication, and impacts sedation and side effects such as hypotension, bradycardia, and nausea. Conducted at Sheikh Zayed Medical College in Rahim Yar Khan, Pakistan, the trial will involve 80 participants and will measure pain using the Visual Analogue Scale (VAS), along with monitoring other vital parameters and complications over 12 hours post-surgery. The primary objective is to determine if the addition of dexmedetomidine provides superior pain control without significantly increasing side effects.
详细描述
This randomized controlled trial will assess the comparative effectiveness of bupivacaine with and without dexmedetomidine in managing postoperative pain following abdominal surgeries. The study will be conducted at Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, Pakistan. A total of 80 patients, aged 21-45 years, undergoing elective abdominal surgeries will be included. These participants will be randomly divided into two groups: Group A will receive a combination of bupivacaine and dexmedetomidine, and Group B will receive only bupivacaine.
The primary outcome is pain relief, assessed using the Visual Analogue Scale (VAS) at multiple time points. Secondary outcomes include the Ramsay Sedation Score, heart rate, mean arterial pressure, and the occurrence of side effects such as hypotension, bradycardia, and nausea. Rescue analgesia will be provided if the VAS score exceeds 4. Both groups will receive ultrasound-guided TAP blocks at the end of their surgeries.
The study aims to evaluate whether the addition of dexmedetomidine improves the duration of analgesia and reduces the need for additional analgesics without exacerbating side effects. The null hypothesis is that there will be no significant difference in pain relief between the two groups, while the alternative hypothesis is that dexmedetomidine will provide superior analgesia.
Statistical analysis will be performed using SPSS v23, with a significance level set at p < 0.05. Data will be analyzed for both quantitative outcomes (e.g., pain scores, heart rate, blood pressure) and qualitative outcomes (e.g., side effects). Stratification by age, gender, and comorbidities will control for potential confounding variables.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study will use a double-blind design, where both the participants and care providers (including anesthesiologists) are unaware of the treatment allocation. The outcomes assessors are also blinded to ensure unbiased pain assessment.
入排标准
- 年龄范围
- 21 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 to 45 years.
- •Undergoing elective abdominal surgery (exploratory laparotomy, ileostomy reversal, laparoscopic/open cholecystectomy, mesh repair of paraumbilical hernias).
- •The patient must be capable of providing informed consent.
排除标准
- •Severe allergies to local anesthetics.
- •Pre-existing chronic pain conditions.
- •Participation in another clinical trial within the past 30 days.
研究组 & 干预措施
Bupivacaine + Dexmedetomidine (TAP Block)
Participants in this arm will receive a combination of 20 ml of 0.25% bupivacaine and 1 mcg/kg dexmedetomidine administered via an ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management following abdominal surgery
干预措施: Bupivacaine (TAP Block) (Drug)
Bupivacaine Only (TAP Block)
Participants in this arm will receive 20 ml of 0.25% bupivacaine administered via an ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management following abdominal surgery
干预措施: Bupivacaine with Dexmedetomidine (TAP Block) (Drug)
结局指标
主要结局
Postoperative Pain Relief (Visual Analogue Scale - VAS)
时间窗: Time Frame: 1-12 hours post-surgery.
The primary outcome is postoperative pain level, measured using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate worse pain. Pain scores will be recorded at 1, 3, 6, 9, and 12 hours post-surgery.
次要结局
- Sedation Level (Ramsay Sedation Scale)(Time Frame: Up to 12 hours post-surgery.)
研究者
Rameesha Musharaf
POST GRADUATE RESIDENT (ANESTHESIA)
Sheikh Zayed Medical College
