"Dexa vs Dexmedetomidine With Bupivacaine in TAP Block for Laparotomy Analgesia
Comparison Of Dexamethasone Versus Dexmedetomidine As An Adjuvant To 0.25% Bupivacaine In Ultrasound Guided Tap Block On Post-Op Analgesia Duration In Patients Undergoing Laparotomy
研究概览
详细说明
After approval of synopsis by the research board and ethical committee and Research department CPSP Karachi, the data collection process will begin. The study will be conducted in the Anesthesia Department of Sahiwal Teaching Hospital Sahiwal. Written informed consent will be obtained from all the patients included in the study. Patients aged between 25 to 65 years, belonging to ASA class-I and class-II, scheduled for laparotomy will be divided into 2 groups of 48 patients each:
- Group A: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2 ml Dexamethasone 8mg.
- Group B: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2ml Dexmedetomidine (1µg/Kg diluted in 2ml saline).
At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation. Patients will be observed for any complication like signs of local anesthetic toxicity or hematoma formation at site of block. In PACU and surgical unit, Visual Analogue Scale Score (VAS) will be recorded at arrival to PACU 2, 4, 6, 12 and 24 hours post-operative. A VAS score of ≤3 will be considered satisfactory pain relief. If patients have inadequate analgesia, supplementary rescue analgesia will be given in the form of IV ketorolac 30mg at VAS ≥4. The time of first request for rescue analgesic will be recorded. Post-operative nausea and vomiting will be documented according to a categorical scale: 0 none, 1 nausea, 2 vomiting, 3 nausea and vomiting. Hemodynamic variables such as heart rate and mean arterial pressure will be recorded. The primary outcome will be to compare the time for first rescue analgesia. The secondary outcome will be assessment of postoperative pain using VAS score at 2, 6, 12, 18 and 24 hrs.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Dr Maryam Mumtaz, MBBS
- 电话号码:00923336238201
- 邮箱:Maryamsumra3@gmail.com
研究联系人备份
- 姓名:Dr Muhammad Shahid
- 电话号码:00923336173056
- 邮箱:shahidnishtar@gmail.com
学习地点
-
-
Punjab Province
-
Sahiwal、Punjab Province、巴基斯坦、57000
- 招聘中
- Sahiwal Medical College
-
接触:
- Dr Rao Riaz ul Haq, FCPS
- 电话号码:009240452470
- 邮箱:slmcswl@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients undergoing laparotomy.
- Patients aged 25 to 65 years.
- Both genders.
- Patients with ASA Class I, II.
Exclusion Criteria:
- Patients who do not give consent.
- Patients with Comorbidities like DM, HTN, CKD, CLD.
- Patients with bleeding disorders.
- Infection at site of injection.
- Allergy to any drug, local anaesthetic, or other drugs used.
- Patients with polytrauma.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:GROUP A
GROUP BUPIVACAINE+DEXAMETHASONE
|
At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed using ultrasound machine.
The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line.
The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles.
Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.
其他名称:
|
|
其他:GROUP B
GROUP BUPIVACAINE+DEXAMETHASONE+DEXMEDETOMIDINE
|
At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine.
The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line.
The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles.
Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
postoperative pain
大体时间:24 hours
|
Duration of postop analgesia
|
24 hours
|
合作者和调查者
调查人员
- 研究主任:Adeel Riaz, MD、Sahiwal medical college sahiwal
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 161/IRB/SLMC/SWL
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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